MRI-first targeted-biopsy pathway · Long-term prostate-cancer mortality equivalence — Evidence Check

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionSelected long-term mortality question and original valuesRequired	The long-term cancer-mortality-equivalence subclaim is graded ?, with the preserved note that this was not a trial endpoint. Parent C56 is the verdict context for detection and biopsy avoidance. S01 S02 S03	Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Subclaim score/status/axes are absent and are not filled from parent values. No new mortality effect, grade or equivalence is certified. Existing content review is incomplete.	Selected existing question, grade/note, parent context and presence of score/status/axes	Update research linking the original question with additional material; no new search, calculation or trial was performed here.
2	Unverified	Full text not readStored summary read	N02 · Evidence conditionDefinition of long-term prostate-cancer mortalityRequired	The original text says reduced biopsy does not establish equal long-term prostate-cancer mortality. Distinguish cancer-detection rates, cumulative diagnosis and biopsy avoidance. S01 S02 S03	Currently needed information is unverified in the preserved summary. Cause-specific/all-cause mortality, adjudication procedures, event counts, long-term periods and censoring/omissions are unverified. Existing content review is incomplete.	Definition, adjudication and follow-up time for the selected mortality outcome	A follow-up research proposal distinguishing the detection pathway from long-term mortality; no new investigation, calculation or trial is performed in this conversion.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionInitial biopsy and actual populationRequired	PRECISE compared an MRI pathway before initial biopsy with standard TRUS at 5 Canadian academic centers. The population in direct mortality material is currently unverified. S01 S03	Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Detailed eligibility, baseline risk/PSA, age, MRI/pathology and arm characteristics, and mortality analysis populations are unverified. Existing content review is incomplete.	Pathway-trial recruitment conditions and the mortality-question population	A follow-up research proposal on population conditions and the application scope of long-term outcomes; no new investigation, calculation or trial is performed in this conversion.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionMRI-first targeted pathwayRequired	Preserve the original pathway omitting biopsy after negative MRI and using only targeted biopsy for visible lesions. Do not turn it into long-term mortality reduction/equivalence or individual test/biopsy guidance. S01 S03	Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Imaging criteria, actual performance/deviations, targeted/systematic biopsy composition and subsequent tests/treatments are unverified. Existing content review is incomplete.	Initial testing/biopsy pathway and actual exposure	A research proposal on relationships between the initial pathway and subsequent exposure; no new investigation, calculation or trial is performed in this conversion.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionStandard TRUS and comparison specificationRequired	Preserve PRECISE allocation of standard TRUS 226 versus MRI 227 men. Do not fill in identical postdiagnosis treatment for the two pathways. S01 S03	Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Control test/biopsy details, repeated/structural testing, additional treatment, adherence/crossover and long-term exposures are unverified. Existing content review is incomplete.	Actual control pathway and subsequent care/treatment	A research proposal distinguishing pathways from attribution of subsequent outcomes; no new investigation, calculation or trial is performed in this conversion.
6	Unverified	Full text not readStored summary read	N06 · Evidence conditionMortality equivalence and prespecified specificationRequired	The detection −5 percentage-point noninferiority margin is not an equivalence margin for selected long-term mortality. Preserve the original record that mortality was not a trial endpoint. S01 S02 S03	Currently needed information is unverified in the preserved summary. Prespecified mortality-equivalence thresholds, design/power, between-arm estimates/CIs and tests/models are unverified. No new margins, effects or CIs are created. Existing content review is incomplete.	Prespecified mortality-equivalence margins and two-sided estimates/precision	A research proposal distinguishing equivalence specifications from uncertainty; no new investigation, calculation or trial is performed in this conversion.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionSeparate GG2 detection from mortalityRequired	PRECISE's primary endpoint is the proportion with GG2 or higher cancer detected. PRECISION also concerned significant-cancer detection/biopsy avoidance. Detection is a different outcome from mortality or metastasis. S01 S02 S03	Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Detection composition, pathology/adjudication procedures, missed cancers/subsequent diagnoses and links to long-term mortality are unverified. Existing content review is incomplete.	Detection-endpoint definitions/measurements and their relationship to mortality material	A research proposal on relationships between detection measures and long-term clinical outcomes; no new investigation, calculation or trial is performed in this conversion.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionPRECISE original detection valuesRequired	Preserve MRI 79/227 (35%) versus standard 67/225 (30%), difference +5 percentage points, one-sided 97.5% CI lower bound −3.4 percentage points to ∞ and fulfillment of the −5 percentage-point margin. Do not repurpose these as mortality effects/CIs. S01	Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Original detection models, denominators/missing data/overlap and mortality events/denominators are unverified. No new differences, rates or estimates are calculated. Existing content review is incomplete.	Detection comparison, denominators, original estimates and scope	A research proposal distinguishing estimates/specifications for different endpoints; no new investigation, calculation or trial is performed in this conversion.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionMRI221·83/37%Required	Preserve the original statement that 83 (37%) of 221 actual MRI recipients avoided biopsy after negative imaging. This denominator differs from the 227 randomized men. Do not use it as mortality-equivalence events. S01 S03	Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Details of MRI nonperformance/negative imaging, biopsy adherence, timing/repeats and follow-up/analysis flow are unverified. No new rates or omission counts are calculated. Existing content review is incomplete.	Actual MRI and biopsy-avoidance denominators/timing	A research proposal on relationships between test/biopsy exposure and long-term observation; no new investigation, calculation or trial is performed in this conversion.
10	Partly verified	Full text not readStored summary read	N10 · Evidence condition453·226/227·225/227Required	Preserve PRECISE's 453 randomized men, allocation 226/227 and detection results 225/227 separately. Do not fill these in as verified mortality-analysis denominators or ITT for everyone. S01 S03	Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Exclusions/omissions, deaths/censoring, arm-specific analyses/follow-up and ITT/PP are unverified. Existing content review is incomplete.	Separate randomized, observed, analyzed and mortality populations	A follow-up research proposal on analysis populations and omission assumptions; no new investigation, calculation or trial is performed in this conversion.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionOpen-label design and mortality adjudicationRequired	Preserve PRECISE's multicenter open-label phase 3 randomized noninferiority design. Distinguish the open-label design from direct long-term mortality-adjudication material. S01 S03	Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Allocation/concealment, assessor/analyst masking and long-term cause-specific mortality measurement/linkage procedures are unverified. Existing content review is incomplete.	Allocation/concealment and role-specific test/pathology/mortality procedures	A research proposal on procedures and the bias scope of long-term outcomes; no new investigation, calculation or trial is performed in this conversion.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionPRECISE 2-year follow-upRequired	S03 is the same PRECISE trial's 2024 report of 2-year follow-up. The original context describes no difference in cumulative GG2 or higher diagnoses with retained initial biopsy omission; it is not long-term mortality material. S03	Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Details of 2-year arm-specific diagnosis/observation denominators, timing/omissions, mortality outcomes and later follow-up are unverified. No new events, effects or independent trials are created. Existing content review is incomplete.	Diagnosis/biopsy follow-up of the same trial and the mortality question	A time-point/endpoint-specific follow-up research proposal within the same trial; no new investigation, calculation or trial is performed in this conversion.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionPRECISION500·28%Required	Preserve the original narrative of European PRECISION with 500 participants, 28% biopsy avoidance in the MRI pathway and detection in the same direction. It is a separate original trial from PRECISE but not direct replication of mortality equivalence. S02	Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Arm-specific denominators, exact detection/effects/CIs, margins, mortality definitions/events and long-term follow-up are unverified. Do not newly sum it with 453 men. Existing content review is incomplete.	Separate pathway trial and its relationship to selected mortality	A research proposal distinguishing pathway replication from mortality evidence; no new investigation, calculation or trial is performed in this conversion.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionRegistration, prespecified endpoints and SAPRequired	Preserve PRECISE NCT02936258 and PRECISION NCT02380027. Distinguish the selected note that mortality was not a trial endpoint from detection plans. S01 S02 S03	Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Each registration history, protocol/SAP, long-term mortality plans/follow-up/changes and multiplicity were not read. Existing content review is incomplete.	Original registration questions/periods, plans/changes and correspondence with reports	A research proposal linking prespecified plans to endpoint-specific reports; no new investigation, calculation or trial is performed in this conversion.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionPostdiagnosis treatment and concurrent exposureRequired	Preserve the original comparison of the initial MRI/targeted pathway with standard biopsy. S01 S02 S03	Currently needed information is unverified in the preserved summary. Subsequent treatment/monitoring, other tests, crossover/adherence, cause-specific mortality/competing events and accompanying exposure are unverified. No test/cancer-treatment selection guidance is created. Existing content review is incomplete.	Arm-specific diagnosis, subsequent treatment/tests and mortality attribution	A research proposal on diagnostic pathways, subsequent exposure and mortality attribution; no new investigation, calculation or trial is performed in this conversion.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionPRECISE funding and presentation resourcesRequired	Preserve mentions of Ontario Institute for Cancer Research and Prostate Cancer Canada funding and Movember Foundation resources in presentation material. S01 S03	Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Contracts, support roles, original presentations, analysis/writing/publication costs and authors/COI were not read. Presentation resources are not certified as direct mortality-funding evidence. Existing content review is incomplete.	Original funding/roles and the scope of presentation resources	A research proposal distinguishing support roles and report relationships; no new investigation, calculation or trial is performed in this conversion.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionPRECISION funding-identity gapRequired	Preserve PRECISION funding as the original narrative of European public/nonprofit funding. Do not transfer PRECISE funders or roles. S02	Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Original details of providers, contracts/roles, product/analysis/writing/publication costs and author relationships/COI were not read. Existing content review is incomplete.	Actual providers, roles and disclosures for the separate original trial	A research proposal distinguishing trial-specific support and role scopes; no new investigation, calculation or trial is performed in this conversion.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionEquipment, free support and COIRequired	The preserved narrative says free equipment/products from equipment manufacturers or outsourced analysis were not reported in the original text. S01 S02 S03	Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Do not turn nonreporting into no support, no employee authors/COI or verified independence. Detailed original disclosures for each trial/report were not read. Existing content review is incomplete.	Individual disclosures of equipment/products, analysis, writing/publication and author relationships	A research proposal distinguishing gaps in individual support and declarations; no new investigation, calculation or trial is performed in this conversion.
19	Partly verified	Full text not readStored summary read	N19 · Harm-information gaps supplementing the efficacy tableSeparate biopsy harms from mortalitySupplementary	Preserve PRECISE standard/MRI values: at least 1 adverse event 145/226 (64%) versus 89/227 (40%); grade 3 or higher 10 men (4.4%) versus 8 men (3.5%). Hematuria 48%/19%, hematospermia 42%/22%, pain 32%/15% and prostatitis 4%/<1% are original rates. Retain the interpretation that confirmatory multiplicity-adjusted P values were absent. S01 S03	Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Actual harm definitions/adjudication, repeats, follow-up/arm-specific denominators and long-term mortality/treatment harms are unverified. Numerical differences are not turned into newly certified significance or causality. Existing content review is incomplete.	Harm collection/denominators versus long-term mortality endpoints	A research proposal distinguishing biopsy burden from long-term mortality/harms; no new investigation, calculation or trial is performed in this conversion.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionTrials/reports, independence and summationRequired	S01/S03 are the same PRECISE trial's initial/2-year reports, and S02 is PRECISION. Original independent replication is a historical detection/biopsy-pathway verdict and is not inherited as mortality replication. S01 S02 S03	Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Unique people, report/follow-up correspondence, long-term mortality material and external checks of actual independence are unverified. Do not newly sum arms, time points, bibliographic records or related subclaim tables. Existing content review is incomplete.	Original report–trial–population–endpoint relationships	A research proposal distinguishing the same material from separate clinical evidence; no new investigation, calculation or trial is performed in this conversion.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionOther biopsy compositions and generalizationRequired	Preserve the original narrative that always omitting systematic biopsy in MRI-positive men and long-term mortality equivalence are separate questions. Do not expand detection benefits to every survival/metastasis outcome or care pathway. S01 S02 S03	Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Direct comparisons of biopsy compositions/standards, other populations/institutions and long-term events are unverified. No new test/biopsy/treatment guidance is created. Existing content review is incomplete.	Biopsy composition after positive MRI and outcomes beyond original populations/periods	A research proposal distinguishing the selected question from other conditions; no new investigation, calculation or trial is performed in this conversion.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionOriginal axes, Korean/English text, dates and correctionsRequired	Preserve the subclaim ?/note, parent C56/Caution, B/S/R2/I2/E+/B1, precision not recorded, three false flags, empty override reasons, Korean/English text, 2026-08-26 and empty corrections/deliberation in the complete summary. S01 S02 S03	Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Historical independent replication/cross-checking and margin-fulfillment narratives do not mean current mortality review, external reading or fulfillment of new conditions. Do not fill absent subclaim score/status/axes or parent classification fields. Existing content review is incomplete.	Distinguish subclaim/parent values, dates/corrections and history	A research proposal updating original-material changes and production versions; no new investigation, calculation or trial is performed in this conversion.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionSummary read; external material unreadRequired	The preserved summary was read for production, and bibliography/URLs for PRECISE, PRECISION and the 2-year report are linked. External articles, registration, protocol/SAP and disclosures were unread; access was not attempted. S01 S02 S03	Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. URLs, registration or historical narrative do not elevate external acquisition/reading/review status; external link/click checks were not performed. Existing content review is incomplete.	Actual reading by material, bibliography/URLs and additional-material gaps	A research proposal for scope-specific updates based on actually acquired material; no new investigation, calculation or trial is performed in this conversion.

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23 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: Preserve the original PRECISE MRI-first/standard-TRUS population before initial prostate biopsy and the separate PRECISION population. Distinguish PRECISE at 5 Canadian academic centers: 453 randomized, standard 226/MRI 227, detection denominators 225/227, and actual MRI 221/83 (37%) avoiding biopsy. Do not newly sum with PRECISION 500; actual mortality populations/denominators, baseline risk and long-term observation are unverified.
Ingredient, formulation and route: Preserve the original initial pathway of biopsy omission after negative MRI and targeted-only biopsy after positive MRI. Imaging/lesion criteria, actual biopsy/deviations and later tests/treatments are unverified. Do not make this a verified mortality-equivalence intervention or individual MRI/biopsy/cancer-treatment method.
Dose: Actual test/biopsy counts, composition, adherence/crossover and subsequent treatment/periods are unverified. Preserve PRECISE avoidance of 83/37% among 221 MRI recipients and PRECISION 28% as separate original measures without calculating new denominators, avoidance counts or differences.
Comparator: PRECISE open-label phase 3 randomized noninferiority comparison of standard TRUS with the MRI pathway. PRECISION is another original trial; control/pathway details beyond the summary are unverified. Arm-specific subsequent diagnosis/treatment, concurrent exposure, long-term mortality/censoring and original analyses are unverified.
Measured outcome: Selected long-term cancer-mortality equivalence retains the existing ? and note that this was not a trial endpoint. Cause/adjudication, time, events/denominators, prespecified equivalence margins, between-arm estimates/CIs and power are unverified. PRECISE GG2 or higher detection 79/227 (35%) versus 67/225 (30%), original +5 percentage points and one-sided 97.5% CI −3.4 percentage points to ∞ meeting a −5 percentage-point noninferiority margin concern another endpoint/specification; they are not mortality estimates or equivalence thresholds.
Duration: PRECISE initial 2021 and 2024 2-year follow-up reports concern the same trial. Preserve the original narrative of no difference in cumulative GG2 or higher diagnoses with retained initial biopsy omission at 2 years without using it as long-term mortality material. Actual selected-mortality follow-up periods/censoring, events and longer outcomes are unverified.
Questions outside this scope: Turning the GG2-detection −5 percentage-point noninferiority margin, one-sided CI/difference or biopsy avoidance into long-term mortality estimates/equivalence specifications; Elevating no difference in 2-year cumulative diagnoses or retained biopsy omission into long-term mortality/metastasis equivalence; Certifying PRECISE initial/follow-up reports as new independent trials or PRECISION detection replication as independent mortality replication; Newly summing or repurposing 453/500, arms/time points/reports, MRI 221/83 or randomized/detection denominators as mortality denominators; Elevating original biopsy-symptom rates into new significance/confirmatory harms or using them as mortality effects; Turning unreported equipment/products/analysis or public/nonprofit funding into no support/COI or current verified independence; Inheriting parent scores/axes, historical cross-checks or original narratives as subclaim scores, current review or external reading; New calculations, invented values, effects/CIs, grades, independence certification or instructions for test/biopsy/cancer-treatment selection and other product/symptom care or treatment

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S01 · Klotz L et al. 2021 PRECISE

PubMed

Material type: Multicenter open-label phase 3 randomized noninferiority trial
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: 79/227 (35%) versus 67/225 (30%), difference +5 percentage points, one-sided 97.5% CI −3.4 percentage points to ∞; −5 percentage-point noninferiority margin met. These are original detection/biopsy or diagnostic-follow-up records, not effects on selected long-term mortality. Preserve the existing ?/note that mortality was not a trial endpoint and unverified direct mortality material/specifications.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: S01 PRECISE 2021 and S03 PRECISE 2024 2-year follow-up are reports from the same Canadian trial. Distinguish 453 randomized, standard 226/MRI 227, detection denominators 225/227 and actual MRI 221/83 (37%) avoiding biopsy. GG2 detection 79/227 (35%) versus 67/225 (30%), original +5 percentage points, one-sided 97.5% CI −3.4 percentage points to ∞ and fulfillment of the −5 percentage-point detection margin are not long-term mortality estimates/margins. The 2-year cumulative-GG2-diagnosis/initial-biopsy-omission findings are not mortality material. S02 PRECISION 2018 is a separate European MRI-pathway trial with 500 participants, 28% biopsy avoidance and detection in the same direction. Original independence/replication wording concerns historical detection/biopsy pathways, not direct mortality effects/equivalence replication. Arm-specific detection/precision and long-term mortality events/denominators/timing are unverified. The selected mortality subclaim remains ? with the note that this was not a trial endpoint. Do not repurpose detection/biopsy/2-year diagnosis records as mortality effects or sum the same people/arms, time points/endpoints, bibliographic records or related subclaim tables as new independent trials/participants. Report/material-slot counts are not unique clinical trial, participant or independent-replication totals; no new totals or independence certification are created.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored file	Stored summary	Summary read	Only stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paper	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Protocol	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis plan	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

S02 · Kasivisvanathan V et al. 2018 PRECISION

PubMed

Material type: European multicenter randomized noninferiority trial
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: In the MRI pathway, 28% avoided biopsy and significant-cancer detection was in the same direction. These are original detection/biopsy or diagnostic-follow-up records, not effects on selected long-term mortality. Preserve the existing ?/note that mortality was not a trial endpoint and unverified direct mortality material/specifications.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: S01 PRECISE 2021 and S03 PRECISE 2024 2-year follow-up are reports from the same Canadian trial. Distinguish 453 randomized, standard 226/MRI 227, detection denominators 225/227 and actual MRI 221/83 (37%) avoiding biopsy. GG2 detection 79/227 (35%) versus 67/225 (30%), original +5 percentage points, one-sided 97.5% CI −3.4 percentage points to ∞ and fulfillment of the −5 percentage-point detection margin are not long-term mortality estimates/margins. The 2-year cumulative-GG2-diagnosis/initial-biopsy-omission findings are not mortality material. S02 PRECISION 2018 is a separate European MRI-pathway trial with 500 participants, 28% biopsy avoidance and detection in the same direction. Original independence/replication wording concerns historical detection/biopsy pathways, not direct mortality effects/equivalence replication. Arm-specific detection/precision and long-term mortality events/denominators/timing are unverified. The selected mortality subclaim remains ? with the note that this was not a trial endpoint. Do not repurpose detection/biopsy/2-year diagnosis records as mortality effects or sum the same people/arms, time points/endpoints, bibliographic records or related subclaim tables as new independent trials/participants. Report/material-slot counts are not unique clinical trial, participant or independent-replication totals; no new totals or independence certification are created.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored file	Stored summary	Summary read	Only stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paper	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Protocol	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis plan	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

S03 · Klotz L, et al. Magnetic Resonance Imaging-Targeted Versus Systematic Prostate Biopsies: 2-year Follow-up of PRECISE. Eur Urol Oncol. 2024. PMID: 37838556.

PubMed

Material type: The same PRECISE trial’s 2-year follow-up report; preserved contextual citation
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: Initial biopsy omission was retained at 2-year follow-up of the same trial. Reduced biopsy does not establish equal long-term prostate-cancer mortality. The trial also did not answer whether systematic biopsy can always be omitted in MRI-positive men. At 2 years, cumulative GG2 or higher diagnoses did not differ between arms while initial biopsy omission was retained; this is not long-term mortality material. These original detection/biopsy/diagnostic-follow-up records are not selected long-term mortality effects. Preserve the existing ?/note that mortality was not a trial endpoint and unverified direct mortality material/specifications.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: S01 PRECISE 2021 and S03 PRECISE 2024 2-year follow-up are reports from the same Canadian trial. Distinguish 453 randomized, standard 226/MRI 227, detection denominators 225/227 and actual MRI 221/83 (37%) avoiding biopsy. GG2 detection 79/227 (35%) versus 67/225 (30%), original +5 percentage points, one-sided 97.5% CI −3.4 percentage points to ∞ and fulfillment of the −5 percentage-point detection margin are not long-term mortality estimates/margins. The 2-year cumulative-GG2-diagnosis/initial-biopsy-omission findings are not mortality material. S02 PRECISION 2018 is a separate European MRI-pathway trial with 500 participants, 28% biopsy avoidance and detection in the same direction. Original independence/replication wording concerns historical detection/biopsy pathways, not direct mortality effects/equivalence replication. Arm-specific detection/precision and long-term mortality events/denominators/timing are unverified. The selected mortality subclaim remains ? with the note that this was not a trial endpoint. Do not repurpose detection/biopsy/2-year diagnosis records as mortality effects or sum the same people/arms, time points/endpoints, bibliographic records or related subclaim tables as new independent trials/participants. Report/material-slot counts are not unique clinical trial, participant or independent-replication totals; no new totals or independence certification are created.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored file	Stored summary	Summary read	Only stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paper	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Protocol	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis plan	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

Report counts versus independent study counts

S01 PRECISE 2021 and S03 PRECISE 2024 2-year follow-up are reports from the same Canadian trial. Distinguish 453 randomized, standard 226/MRI 227, detection denominators 225/227 and actual MRI 221/83 (37%) avoiding biopsy. GG2 detection 79/227 (35%) versus 67/225 (30%), original +5 percentage points, one-sided 97.5% CI −3.4 percentage points to ∞ and fulfillment of the −5 percentage-point detection margin are not long-term mortality estimates/margins. The 2-year cumulative-GG2-diagnosis/initial-biopsy-omission findings are not mortality material. S02 PRECISION 2018 is a separate European MRI-pathway trial with 500 participants, 28% biopsy avoidance and detection in the same direction. Original independence/replication wording concerns historical detection/biopsy pathways, not direct mortality effects/equivalence replication. Arm-specific detection/precision and long-term mortality events/denominators/timing are unverified. The selected mortality subclaim remains ? with the note that this was not a trial endpoint. Do not repurpose detection/biopsy/2-year diagnosis records as mortality effects or sum the same people/arms, time points/endpoints, bibliographic records or related subclaim tables as new independent trials/participants. Report/material-slot counts are not unique clinical trial, participant or independent-replication totals; no new totals or independence certification are created.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Selected long-term mortality question and original values

Required materials and conditions: Selected existing question, grade/note, parent context and presence of score/status/axes
Conditions for verification: Selected existing question, grade/note, parent context and presence of score/status/axes: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Selected existing question, grade/note, parent context and presence of score/status/axes to connect the selected question’s needed material with current material.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

N02 · Definition of long-term prostate-cancer mortality

Required materials and conditions: Definition, adjudication and follow-up time for the selected mortality outcome
Conditions for verification: Definition, adjudication and follow-up time for the selected mortality outcome: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Definition, adjudication and follow-up time for the selected mortality outcome to connect the selected question’s needed material with current material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 Table 8.2.a, M03 §3.2.4; custom application; M03 §3.2.4; custom extension boundary; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design

N03 · Initial biopsy and actual population

Required materials and conditions: Pathway-trial recruitment conditions and the mortality-question population
Conditions for verification: Pathway-trial recruitment conditions and the mortality-question population: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Pathway-trial recruitment conditions and the mortality-question population to connect the selected question’s needed material with current material.
Referenced methods: M03 §3.2.1; detailed population conditions are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design

N04 · MRI-first targeted pathway

Required materials and conditions: Initial testing/biopsy pathway and actual exposure
Conditions for verification: Initial testing/biopsy pathway and actual exposure: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Initial testing/biopsy pathway and actual exposure to connect the selected question’s needed material with current material.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are Chamgap’s own design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application

N05 · Standard TRUS and comparison specification

Required materials and conditions: Actual control pathway and subsequent care/treatment
Conditions for verification: Actual control pathway and subsequent care/treatment: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Actual control pathway and subsequent care/treatment to connect the selected question’s needed material with current material.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are Chamgap’s own design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application

N06 · Mortality equivalence and prespecified specification

Required materials and conditions: Prespecified mortality-equivalence margins and two-sided estimates/precision
Conditions for verification: Prespecified mortality-equivalence margins and two-sided estimates/precision: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Prespecified mortality-equivalence margins and two-sided estimates/precision to connect the selected question’s needed material with current material.
Referenced methods: M08 Table 8.2.a and M04 §4.6.3; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design; M03 §3.2.4; Chamgap extension boundary

N07 · Separate GG2 detection from mortality

Required materials and conditions: Detection-endpoint definitions/measurements and their relationship to mortality material
Conditions for verification: Detection-endpoint definitions/measurements and their relationship to mortality material: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Detection-endpoint definitions/measurements and their relationship to mortality material to connect the selected question’s needed material with current material.
Referenced methods: M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary

N08 · PRECISE original detection values

Required materials and conditions: Detection comparison, denominators, original estimates and scope
Conditions for verification: Detection comparison, denominators, original estimates and scope: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Detection comparison, denominators, original estimates and scope to connect the selected question’s needed material with current material.
Referenced methods: M15 §15.3.1–15.3.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design; M04 §4.6.3 and M15 §15.3.1–15.3.3; separation of statuses is Chamgap’s own design

N09 · MRI221·83/37%

Required materials and conditions: Actual MRI and biopsy-avoidance denominators/timing
Conditions for verification: Actual MRI and biopsy-avoidance denominators/timing: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Actual MRI and biopsy-avoidance denominators/timing to connect the selected question’s needed material with current material.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application

N10 · 453·226/227·225/227

Required materials and conditions: Separate randomized, observed, analyzed and mortality populations
Conditions for verification: Separate randomized, observed, analyzed and mortality populations: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Separate randomized, observed, analyzed and mortality populations to connect the selected question’s needed material with current material.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application

N11 · Open-label design and mortality adjudication

Required materials and conditions: Allocation/concealment and role-specific test/pathology/mortality procedures
Conditions for verification: Allocation/concealment and role-specific test/pathology/mortality procedures: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Allocation/concealment and role-specific test/pathology/mortality procedures to connect the selected question’s needed material with current material.
Referenced methods: M08 §§8.1–8.2.3; Chamgap adaptation; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed

N12 · PRECISE 2-year follow-up

Required materials and conditions: Diagnosis/biopsy follow-up of the same trial and the mortality question
Conditions for verification: Diagnosis/biopsy follow-up of the same trial and the mortality question: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Diagnosis/biopsy follow-up of the same trial and the mortality question to connect the selected question’s needed material with current material.
Referenced methods: M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application; M03 §3.2.4 and M15 §15.3.1–15.3.3; question-specific result adaptation is Chamgap’s own design; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design; M03 §3.2.4; Chamgap extension boundary

N13 · PRECISION500·28%

Required materials and conditions: Separate pathway trial and its relationship to selected mortality
Conditions for verification: Separate pathway trial and its relationship to selected mortality: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Separate pathway trial and its relationship to selected mortality to connect the selected question’s needed material with current material.
Referenced methods: M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design; M03 §3.2.4; Chamgap extension boundary

N14 · Registration, prespecified endpoints and SAP

Required materials and conditions: Original registration questions/periods, plans/changes and correspondence with reports
Conditions for verification: Original registration questions/periods, plans/changes and correspondence with reports: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Original registration questions/periods, plans/changes and correspondence with reports to connect the selected question’s needed material with current material.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

N15 · Postdiagnosis treatment and concurrent exposure

Required materials and conditions: Arm-specific diagnosis, subsequent treatment/tests and mortality attribution
Conditions for verification: Arm-specific diagnosis, subsequent treatment/tests and mortality attribution: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Arm-specific diagnosis, subsequent treatment/tests and mortality attribution to connect the selected question’s needed material with current material.
Referenced methods: M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are Chamgap’s own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design

N16 · PRECISE funding and presentation resources

Required materials and conditions: Original funding/roles and the scope of presentation resources
Conditions for verification: Original funding/roles and the scope of presentation resources: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Original funding/roles and the scope of presentation resources to connect the selected question’s needed material with current material.
Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design

N17 · PRECISION funding-identity gap

Required materials and conditions: Actual providers, roles and disclosures for the separate original trial
Conditions for verification: Actual providers, roles and disclosures for the separate original trial: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Actual providers, roles and disclosures for the separate original trial to connect the selected question’s needed material with current material.
Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design

N18 · Equipment, free support and COI

Required materials and conditions: Individual disclosures of equipment/products, analysis, writing/publication and author relationships
Conditions for verification: Individual disclosures of equipment/products, analysis, writing/publication and author relationships: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Individual disclosures of equipment/products, analysis, writing/publication and author relationships to connect the selected question’s needed material with current material.
Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design

N19 · Separate biopsy harms from mortality

Required materials and conditions: Harm collection/denominators versus long-term mortality endpoints
Conditions for verification: Harm collection/denominators versus long-term mortality endpoints: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Supplementary
Application exceptions: Supplement safety-evidence gaps for the selected subclaim. Do not judge safety from detection, other measure/symptom outcomes or parent safety wording, or generate harm incidence or new usage instructions.
Why this condition is needed: A production item distinguishing Harm collection/denominators versus long-term mortality endpoints to connect the selected question’s needed material with current material.
Referenced methods: M19 §19.1.2–19.2.4; detailed distinctions are Chamgap’s own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application

N20 · Trials/reports, independence and summation

Required materials and conditions: Original report–trial–population–endpoint relationships
Conditions for verification: Original report–trial–population–endpoint relationships: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Original report–trial–population–endpoint relationships to connect the selected question’s needed material with current material.
Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

N21 · Other biopsy compositions and generalization

Required materials and conditions: Biopsy composition after positive MRI and outcomes beyond original populations/periods
Conditions for verification: Biopsy composition after positive MRI and outcomes beyond original populations/periods: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Biopsy composition after positive MRI and outcomes beyond original populations/periods to connect the selected question’s needed material with current material.
Referenced methods: M03 §3.2.1; detailed population conditions are custom design; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design; M03 §3.2.4; custom extension boundary

N22 · Original axes, Korean/English text, dates and corrections

Required materials and conditions: Distinguish subclaim/parent values, dates/corrections and history
Conditions for verification: Distinguish subclaim/parent values, dates/corrections and history requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Distinguish subclaim/parent values, dates/corrections and history to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed

N23 · Summary read; external material unread

Required materials and conditions: Actual reading by material, bibliography/URLs and additional-material gaps
Conditions for verification: Actual reading by material, bibliography/URLs and additional-material gaps: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item distinguishing Actual reading by material, bibliography/URLs and additional-material gaps to connect the selected question’s needed material with current material.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

What the statuses mean

Met: Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.
Partly verified: Some information in the stored summary is linked into the table. External comparison/content review is not complete.
Unverified: The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.
Review incomplete: Existing content review remains incomplete.
Not reported: Not reported within the stored material actually read; not extended to the entire primary paper.
Inaccessible: Means an actual access failure. Access not attempted here is not assigned this state.
Not applicable: Not used as a substitute for an evidence gap.
Conflicting data: Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.
Insufficient evidence for the conditions: Marks a gap in additional material required by the selected conditions; not a new efficacy grade.

Change history

2026-10-12 · Public page/material version 1.0

Reader pages and materials were prepared from the existing 23 items. No new clinical search, change in verification status or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Selected long-term mortality question and original values

Current findings: The long-term cancer-mortality-equivalence subclaim is graded ?, with the preserved note that this was not a trial endpoint. Parent C56 is the verdict context for detection and biopsy avoidance.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Subclaim score/status/axes are absent and are not filled from parent values. No new mortality effect, grade or equivalence is certified. Existing content review is incomplete.
Reason for missing information: Subclaim score/status/axes are absent and are not filled from parent values. No new mortality effect, grade or equivalence is certified.
Required materials and conditions: Selected existing question, grade/note, parent context and presence of score/status/axes
Materials to obtain first: Records distinguishing the selected question from the parent verdict
Further research: Update research linking the original question with additional material; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Selected existing question, grade/note, parent context and presence of score/status/axes: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Selected existing question, grade/note, parent context and presence of score/status/axes to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

Related sources S01 S02 S03

N02 · Definition of long-term prostate-cancer mortality

Current findings: The original text says reduced biopsy does not establish equal long-term prostate-cancer mortality. Distinguish cancer-detection rates, cumulative diagnosis and biopsy avoidance.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Currently needed information is unverified in the preserved summary. Cause-specific/all-cause mortality, adjudication procedures, event counts, long-term periods and censoring/omissions are unverified. Existing content review is incomplete.
Reason for missing information: Cause-specific/all-cause mortality, adjudication procedures, event counts, long-term periods and censoring/omissions are unverified.
Required materials and conditions: Definition, adjudication and follow-up time for the selected mortality outcome
Materials to obtain first: Mortality definitions, adjudication/registry linkage and long-term follow-up material
Further research: A follow-up research proposal distinguishing the detection pathway from long-term mortality; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Definition, adjudication and follow-up time for the selected mortality outcome: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Definition, adjudication and follow-up time for the selected mortality outcome to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 Table 8.2.a, M03 §3.2.4; custom application; M03 §3.2.4; custom extension boundary; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design

Related sources S01 S02 S03

N03 · Initial biopsy and actual population

Current findings: PRECISE compared an MRI pathway before initial biopsy with standard TRUS at 5 Canadian academic centers. The population in direct mortality material is currently unverified.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Detailed eligibility, baseline risk/PSA, age, MRI/pathology and arm characteristics, and mortality analysis populations are unverified. Existing content review is incomplete.
Reason for missing information: Detailed eligibility, baseline risk/PSA, age, MRI/pathology and arm characteristics, and mortality analysis populations are unverified.
Required materials and conditions: Pathway-trial recruitment conditions and the mortality-question population
Materials to obtain first: Original recruitment/baseline material and long-term follow-up populations
Further research: A follow-up research proposal on population conditions and the application scope of long-term outcomes; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Pathway-trial recruitment conditions and the mortality-question population: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Pathway-trial recruitment conditions and the mortality-question population to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.1; detailed population conditions are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design

Related sources S01 S03

N04 · MRI-first targeted pathway

Current findings: Preserve the original pathway omitting biopsy after negative MRI and using only targeted biopsy for visible lesions. Do not turn it into long-term mortality reduction/equivalence or individual test/biopsy guidance.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Imaging criteria, actual performance/deviations, targeted/systematic biopsy composition and subsequent tests/treatments are unverified. Existing content review is incomplete.
Reason for missing information: Imaging criteria, actual performance/deviations, targeted/systematic biopsy composition and subsequent tests/treatments are unverified.
Required materials and conditions: Initial testing/biopsy pathway and actual exposure
Materials to obtain first: Original pathway, actual tests/biopsies, deviations and follow-up material
Further research: A research proposal on relationships between the initial pathway and subsequent exposure; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Initial testing/biopsy pathway and actual exposure: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Initial testing/biopsy pathway and actual exposure to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are Chamgap’s own design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application

Related sources S01 S03

N05 · Standard TRUS and comparison specification

Current findings: Preserve PRECISE allocation of standard TRUS 226 versus MRI 227 men. Do not fill in identical postdiagnosis treatment for the two pathways.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Control test/biopsy details, repeated/structural testing, additional treatment, adherence/crossover and long-term exposures are unverified. Existing content review is incomplete.
Reason for missing information: Control test/biopsy details, repeated/structural testing, additional treatment, adherence/crossover and long-term exposures are unverified.
Required materials and conditions: Actual control pathway and subsequent care/treatment
Materials to obtain first: Control/follow-up pathways, actual care/treatment and deviation records
Further research: A research proposal distinguishing pathways from attribution of subsequent outcomes; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Actual control pathway and subsequent care/treatment: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Actual control pathway and subsequent care/treatment to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are Chamgap’s own design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application

Related sources S01 S03

N06 · Mortality equivalence and prespecified specification

Current findings: The detection −5 percentage-point noninferiority margin is not an equivalence margin for selected long-term mortality. Preserve the original record that mortality was not a trial endpoint.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Currently needed information is unverified in the preserved summary. Prespecified mortality-equivalence thresholds, design/power, between-arm estimates/CIs and tests/models are unverified. No new margins, effects or CIs are created. Existing content review is incomplete.
Reason for missing information: Prespecified mortality-equivalence thresholds, design/power, between-arm estimates/CIs and tests/models are unverified. No new margins, effects or CIs are created.
Required materials and conditions: Prespecified mortality-equivalence margins and two-sided estimates/precision
Materials to obtain first: Original mortality-equivalence plans, power and estimate/CI material
Further research: A research proposal distinguishing equivalence specifications from uncertainty; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Prespecified mortality-equivalence margins and two-sided estimates/precision: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Prespecified mortality-equivalence margins and two-sided estimates/precision to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a and M04 §4.6.3; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design; M03 §3.2.4; Chamgap extension boundary

Related sources S01 S02 S03

N07 · Separate GG2 detection from mortality

Current findings: PRECISE's primary endpoint is the proportion with GG2 or higher cancer detected. PRECISION also concerned significant-cancer detection/biopsy avoidance. Detection is a different outcome from mortality or metastasis.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Detection composition, pathology/adjudication procedures, missed cancers/subsequent diagnoses and links to long-term mortality are unverified. Existing content review is incomplete.
Reason for missing information: Detection composition, pathology/adjudication procedures, missed cancers/subsequent diagnoses and links to long-term mortality are unverified.
Required materials and conditions: Detection-endpoint definitions/measurements and their relationship to mortality material
Materials to obtain first: Pathology/detection definitions and links between subsequent diagnosis and mortality
Further research: A research proposal on relationships between detection measures and long-term clinical outcomes; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Detection-endpoint definitions/measurements and their relationship to mortality material: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Detection-endpoint definitions/measurements and their relationship to mortality material to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary

Related sources S01 S02 S03

N08 · PRECISE original detection values

Current findings: Preserve MRI 79/227 (35%) versus standard 67/225 (30%), difference +5 percentage points, one-sided 97.5% CI lower bound −3.4 percentage points to ∞ and fulfillment of the −5 percentage-point margin. Do not repurpose these as mortality effects/CIs.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Original detection models, denominators/missing data/overlap and mortality events/denominators are unverified. No new differences, rates or estimates are calculated. Existing content review is incomplete.
Reason for missing information: Original detection models, denominators/missing data/overlap and mortality events/denominators are unverified. No new differences, rates or estimates are calculated.
Required materials and conditions: Detection comparison, denominators, original estimates and scope
Materials to obtain first: Original detection analyses/populations and separate mortality material
Further research: A research proposal distinguishing estimates/specifications for different endpoints; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Detection comparison, denominators, original estimates and scope: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Detection comparison, denominators, original estimates and scope to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M15 §15.3.1–15.3.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design; M04 §4.6.3 and M15 §15.3.1–15.3.3; separation of statuses is Chamgap’s own design

Related sources S01

N09 · MRI221·83/37%

Current findings: Preserve the original statement that 83 (37%) of 221 actual MRI recipients avoided biopsy after negative imaging. This denominator differs from the 227 randomized men. Do not use it as mortality-equivalence events.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Details of MRI nonperformance/negative imaging, biopsy adherence, timing/repeats and follow-up/analysis flow are unverified. No new rates or omission counts are calculated. Existing content review is incomplete.
Reason for missing information: Details of MRI nonperformance/negative imaging, biopsy adherence, timing/repeats and follow-up/analysis flow are unverified. No new rates or omission counts are calculated.
Required materials and conditions: Actual MRI and biopsy-avoidance denominators/timing
Materials to obtain first: MRI/biopsy, denominators/timing and actual implementation/follow-up material
Further research: A research proposal on relationships between test/biopsy exposure and long-term observation; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Actual MRI and biopsy-avoidance denominators/timing: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Actual MRI and biopsy-avoidance denominators/timing to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application

Related sources S01 S03

N10 · 453·226/227·225/227

Current findings: Preserve PRECISE's 453 randomized men, allocation 226/227 and detection results 225/227 separately. Do not fill these in as verified mortality-analysis denominators or ITT for everyone.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Exclusions/omissions, deaths/censoring, arm-specific analyses/follow-up and ITT/PP are unverified. Existing content review is incomplete.
Reason for missing information: Exclusions/omissions, deaths/censoring, arm-specific analyses/follow-up and ITT/PP are unverified.
Required materials and conditions: Separate randomized, observed, analyzed and mortality populations
Materials to obtain first: Randomization → endpoint-specific observation/analysis and long-term follow-up flow
Further research: A follow-up research proposal on analysis populations and omission assumptions; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Separate randomized, observed, analyzed and mortality populations: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Separate randomized, observed, analyzed and mortality populations to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application

Related sources S01 S03

N11 · Open-label design and mortality adjudication

Current findings: Preserve PRECISE's multicenter open-label phase 3 randomized noninferiority design. Distinguish the open-label design from direct long-term mortality-adjudication material.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Allocation/concealment, assessor/analyst masking and long-term cause-specific mortality measurement/linkage procedures are unverified. Existing content review is incomplete.
Reason for missing information: Allocation/concealment, assessor/analyst masking and long-term cause-specific mortality measurement/linkage procedures are unverified.
Required materials and conditions: Allocation/concealment and role-specific test/pathology/mortality procedures
Materials to obtain first: Allocation, measurement/adjudication and long-term mortality-linkage records
Further research: A research proposal on procedures and the bias scope of long-term outcomes; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Allocation/concealment and role-specific test/pathology/mortality procedures: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Allocation/concealment and role-specific test/pathology/mortality procedures to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 §§8.1–8.2.3; Chamgap adaptation; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed

Related sources S01 S03

N12 · PRECISE 2-year follow-up

Current findings: S03 is the same PRECISE trial's 2024 report of 2-year follow-up. The original context describes no difference in cumulative GG2 or higher diagnoses with retained initial biopsy omission; it is not long-term mortality material.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Details of 2-year arm-specific diagnosis/observation denominators, timing/omissions, mortality outcomes and later follow-up are unverified. No new events, effects or independent trials are created. Existing content review is incomplete.
Reason for missing information: Details of 2-year arm-specific diagnosis/observation denominators, timing/omissions, mortality outcomes and later follow-up are unverified. No new events, effects or independent trials are created.
Required materials and conditions: Diagnosis/biopsy follow-up of the same trial and the mortality question
Materials to obtain first: Original follow-up report, populations/diagnosis/biopsy and long-term mortality material
Further research: A time-point/endpoint-specific follow-up research proposal within the same trial; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Diagnosis/biopsy follow-up of the same trial and the mortality question: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Diagnosis/biopsy follow-up of the same trial and the mortality question to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application; M03 §3.2.4 and M15 §15.3.1–15.3.3; question-specific result adaptation is Chamgap’s own design; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design; M03 §3.2.4; Chamgap extension boundary

Related sources S03

N13 · PRECISION500·28%

Current findings: Preserve the original narrative of European PRECISION with 500 participants, 28% biopsy avoidance in the MRI pathway and detection in the same direction. It is a separate original trial from PRECISE but not direct replication of mortality equivalence.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Arm-specific denominators, exact detection/effects/CIs, margins, mortality definitions/events and long-term follow-up are unverified. Do not newly sum it with 453 men. Existing content review is incomplete.
Reason for missing information: Arm-specific denominators, exact detection/effects/CIs, margins, mortality definitions/events and long-term follow-up are unverified. Do not newly sum it with 453 men.
Required materials and conditions: Separate pathway trial and its relationship to selected mortality
Materials to obtain first: PRECISION original plans/results and mortality/follow-up material
Further research: A research proposal distinguishing pathway replication from mortality evidence; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Separate pathway trial and its relationship to selected mortality: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Separate pathway trial and its relationship to selected mortality to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design; M03 §3.2.4; Chamgap extension boundary

Related sources S02

N14 · Registration, prespecified endpoints and SAP

Current findings: Preserve PRECISE NCT02936258 and PRECISION NCT02380027. Distinguish the selected note that mortality was not a trial endpoint from detection plans.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Each registration history, protocol/SAP, long-term mortality plans/follow-up/changes and multiplicity were not read. Existing content review is incomplete.
Reason for missing information: Each registration history, protocol/SAP, long-term mortality plans/follow-up/changes and multiplicity were not read.
Required materials and conditions: Original registration questions/periods, plans/changes and correspondence with reports
Materials to obtain first: Each registration/plan, mortality follow-up specification and report correspondence
Further research: A research proposal linking prespecified plans to endpoint-specific reports; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original registration questions/periods, plans/changes and correspondence with reports: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Original registration questions/periods, plans/changes and correspondence with reports to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

Related sources S01 S02 S03

N15 · Postdiagnosis treatment and concurrent exposure

Current findings: Preserve the original comparison of the initial MRI/targeted pathway with standard biopsy.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Currently needed information is unverified in the preserved summary. Subsequent treatment/monitoring, other tests, crossover/adherence, cause-specific mortality/competing events and accompanying exposure are unverified. No test/cancer-treatment selection guidance is created. Existing content review is incomplete.
Reason for missing information: Subsequent treatment/monitoring, other tests, crossover/adherence, cause-specific mortality/competing events and accompanying exposure are unverified. No test/cancer-treatment selection guidance is created.
Required materials and conditions: Arm-specific diagnosis, subsequent treatment/tests and mortality attribution
Materials to obtain first: Arm-specific subsequent testing/treatment, exposure and long-term event material
Further research: A research proposal on diagnostic pathways, subsequent exposure and mortality attribution; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Arm-specific diagnosis, subsequent treatment/tests and mortality attribution: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Arm-specific diagnosis, subsequent treatment/tests and mortality attribution to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are Chamgap’s own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design

Related sources S01 S02 S03

N16 · PRECISE funding and presentation resources

Current findings: Preserve mentions of Ontario Institute for Cancer Research and Prostate Cancer Canada funding and Movember Foundation resources in presentation material.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Contracts, support roles, original presentations, analysis/writing/publication costs and authors/COI were not read. Presentation resources are not certified as direct mortality-funding evidence. Existing content review is incomplete.
Reason for missing information: Contracts, support roles, original presentations, analysis/writing/publication costs and authors/COI were not read. Presentation resources are not certified as direct mortality-funding evidence.
Required materials and conditions: Original funding/roles and the scope of presentation resources
Materials to obtain first: Funding contracts, presentations/original disclosures and contribution records
Further research: A research proposal distinguishing support roles and report relationships; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original funding/roles and the scope of presentation resources: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Original funding/roles and the scope of presentation resources to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design

Related sources S01 S03

N17 · PRECISION funding-identity gap

Current findings: Preserve PRECISION funding as the original narrative of European public/nonprofit funding. Do not transfer PRECISE funders or roles.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Original details of providers, contracts/roles, product/analysis/writing/publication costs and author relationships/COI were not read. Existing content review is incomplete.
Reason for missing information: Original details of providers, contracts/roles, product/analysis/writing/publication costs and author relationships/COI were not read.
Required materials and conditions: Actual providers, roles and disclosures for the separate original trial
Materials to obtain first: PRECISION original funding/support and author/COI disclosures
Further research: A research proposal distinguishing trial-specific support and role scopes; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Actual providers, roles and disclosures for the separate original trial: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Actual providers, roles and disclosures for the separate original trial to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design

Related sources S02

N18 · Equipment, free support and COI

Current findings: The preserved narrative says free equipment/products from equipment manufacturers or outsourced analysis were not reported in the original text.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Do not turn nonreporting into no support, no employee authors/COI or verified independence. Detailed original disclosures for each trial/report were not read. Existing content review is incomplete.
Reason for missing information: Do not turn nonreporting into no support, no employee authors/COI or verified independence. Detailed original disclosures for each trial/report were not read.
Required materials and conditions: Individual disclosures of equipment/products, analysis, writing/publication and author relationships
Materials to obtain first: Trial-specific equipment/products, support/contributions and employment/COI material
Further research: A research proposal distinguishing gaps in individual support and declarations; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Individual disclosures of equipment/products, analysis, writing/publication and author relationships: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Individual disclosures of equipment/products, analysis, writing/publication and author relationships to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design

Related sources S01 S02 S03

N19 · Separate biopsy harms from mortality

Current findings: Preserve PRECISE standard/MRI values: at least 1 adverse event 145/226 (64%) versus 89/227 (40%); grade 3 or higher 10 men (4.4%) versus 8 men (3.5%). Hematuria 48%/19%, hematospermia 42%/22%, pain 32%/15% and prostatitis 4%/<1% are original rates. Retain the interpretation that confirmatory multiplicity-adjusted P values were absent.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Actual harm definitions/adjudication, repeats, follow-up/arm-specific denominators and long-term mortality/treatment harms are unverified. Numerical differences are not turned into newly certified significance or causality. Existing content review is incomplete.
Reason for missing information: Actual harm definitions/adjudication, repeats, follow-up/arm-specific denominators and long-term mortality/treatment harms are unverified. Numerical differences are not turned into newly certified significance or causality.
Required materials and conditions: Harm collection/denominators versus long-term mortality endpoints
Materials to obtain first: Original harm collection, arm-specific events/denominators and multiplicity/follow-up material
Further research: A research proposal distinguishing biopsy burden from long-term mortality/harms; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Harm collection/denominators versus long-term mortality endpoints: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Harm collection/denominators versus long-term mortality endpoints to connect the selected question’s needed material with current material.
Application exceptions: Supplement safety-evidence gaps for the selected subclaim. Do not judge safety from detection, other measure/symptom outcomes or parent safety wording, or generate harm incidence or new usage instructions.
Referenced methods: M19 §19.1.2–19.2.4; detailed distinctions are Chamgap’s own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application

Related sources S01 S03

N20 · Trials/reports, independence and summation

Current findings: S01/S03 are the same PRECISE trial's initial/2-year reports, and S02 is PRECISION. Original independent replication is a historical detection/biopsy-pathway verdict and is not inherited as mortality replication.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Unique people, report/follow-up correspondence, long-term mortality material and external checks of actual independence are unverified. Do not newly sum arms, time points, bibliographic records or related subclaim tables. Existing content review is incomplete.
Reason for missing information: Unique people, report/follow-up correspondence, long-term mortality material and external checks of actual independence are unverified. Do not newly sum arms, time points, bibliographic records or related subclaim tables.
Required materials and conditions: Original report–trial–population–endpoint relationships
Materials to obtain first: Report/registration/population/time-point/endpoint relationships and mortality evidence
Further research: A research proposal distinguishing the same material from separate clinical evidence; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original report–trial–population–endpoint relationships: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Original report–trial–population–endpoint relationships to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

Related sources S01 S02 S03

N21 · Other biopsy compositions and generalization

Current findings: Preserve the original narrative that always omitting systematic biopsy in MRI-positive men and long-term mortality equivalence are separate questions. Do not expand detection benefits to every survival/metastasis outcome or care pathway.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Direct comparisons of biopsy compositions/standards, other populations/institutions and long-term events are unverified. No new test/biopsy/treatment guidance is created. Existing content review is incomplete.
Reason for missing information: Direct comparisons of biopsy compositions/standards, other populations/institutions and long-term events are unverified. No new test/biopsy/treatment guidance is created.
Required materials and conditions: Biopsy composition after positive MRI and outcomes beyond original populations/periods
Materials to obtain first: Material by population/pathway/biopsy composition and long-term outcome
Further research: A research proposal distinguishing the selected question from other conditions; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Biopsy composition after positive MRI and outcomes beyond original populations/periods: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Biopsy composition after positive MRI and outcomes beyond original populations/periods to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.1; detailed population conditions are custom design; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design; M03 §3.2.4; custom extension boundary

Related sources S01 S02 S03

N22 · Original axes, Korean/English text, dates and corrections

Current findings: Preserve the subclaim ?/note, parent C56/Caution, B/S/R2/I2/E+/B1, precision not recorded, three false flags, empty override reasons, Korean/English text, 2026-08-26 and empty corrections/deliberation in the complete summary.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. Historical independent replication/cross-checking and margin-fulfillment narratives do not mean current mortality review, external reading or fulfillment of new conditions. Do not fill absent subclaim score/status/axes or parent classification fields. Existing content review is incomplete.
Reason for missing information: Historical independent replication/cross-checking and margin-fulfillment narratives do not mean current mortality review, external reading or fulfillment of new conditions. Do not fill absent subclaim score/status/axes or parent classification fields.
Required materials and conditions: Distinguish subclaim/parent values, dates/corrections and history
Materials to obtain first: Original verdict, correction/change text and user comments
Further research: A research proposal updating original-material changes and production versions; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Distinguish subclaim/parent values, dates/corrections and history requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Distinguish subclaim/parent values, dates/corrections and history to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed

Related sources S01 S02 S03

N23 · Summary read; external material unread

Current findings: The preserved summary was read for production, and bibliography/URLs for PRECISE, PRECISION and the 2-year report are linked. External articles, registration, protocol/SAP and disclosures were unread; access was not attempted.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original material is unread and existing content review is incomplete. URLs, registration or historical narrative do not elevate external acquisition/reading/review status; external link/click checks were not performed. Existing content review is incomplete.
Reason for missing information: URLs, registration or historical narrative do not elevate external acquisition/reading/review status; external link/click checks were not performed.
Required materials and conditions: Actual reading by material, bibliography/URLs and additional-material gaps
Materials to obtain first: Each original report/registration/plan, long-term mortality/disclosures and user comments
Further research: A research proposal for scope-specific updates based on actually acquired material; no new investigation, calculation or trial is performed in this conversion.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Actual reading by material, bibliography/URLs and additional-material gaps: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.
Why this condition is needed: A production item distinguishing Actual reading by material, bibliography/URLs and additional-material gaps to connect the selected question’s needed material with current material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources S01 S02 S03