# MRI-first targeted-biopsy pathway · Long-term prostate-cancer mortality equivalence — Evidence Check Verdict 2958 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-08-26 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-12 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - 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 ## Checklist items ### N01 · Selected long-term mortality question and original values Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Unverified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Preserve PRECISE allocation of standard TRUS 226 versus MRI 227 men. Do not fill in identical postdiagnosis treatment for the two pathways. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Unverified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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% Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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% Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Preserve PRECISE NCT02936258 and PRECISION NCT02380027. Distinguish the selected note that mortality was not a trial endpoint from detection plans. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Unverified Reading scope: Summary read; external material unread - Current findings: Preserve the original comparison of the initial MRI/targeted pathway with standard biopsy. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Preserve mentions of Ontario Institute for Cancer Research and Prostate Cancer Canada funding and Movember Foundation resources in presentation material. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Preserve PRECISION funding as the original narrative of European public/nonprofit funding. Do not transfer PRECISE funders or roles. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The preserved narrative says free equipment/products from equipment manufacturers or outsourced analysis were not reported in the original text. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 ## Evidence and sources ### S01 Klotz L et al. 2021 PRECISE [PubMed](https://pubmed.ncbi.nlm.nih.gov/33538782/) Materials actually read: Summary read; external material unread Findings recorded in the 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 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. | 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](https://pubmed.ncbi.nlm.nih.gov/29552975/) Materials actually read: Summary read; external material unread Findings recorded in the 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 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. | 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](https://pubmed.ncbi.nlm.nih.gov/37838556/) Materials actually read: Summary read; external material unread Findings recorded in the 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 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. | 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. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Preserved method HTML copies; no current method-content re-review or official tool execution - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Preserved method HTML copies; no current method-content re-review or official tool execution - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Preserved method HTML copies; no current method-content re-review or official tool execution - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 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.