# PSA-led active monitoring × Claim of equivalent metastasis and clinical progression

Verdict 2974 · 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: 2026-10-14

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: 1,643 men aged 50–69 with PSA-detected localized prostate cancer. Original monitoring 545/surgery 553/radiotherapy 545, complete follow-up for 1,610/1,643 (98%). Endpoint-specific valid/risk denominators, risk/stage, missingness/withdrawal details remain unverified.
- Ingredient, formulation and route: ProtecT’s PSA-led active monitoring, not repurposed as identical to contemporary active surveillance with more MRI/regular repeat biopsy. Preserve original rescue/radical-treatment switching by many participants; no testing/surveillance/treatment-selection or implementation instructions.
- Dose: Only assigned strategies and median 15-year follow-up, range 11–21, are preserved. Actual monitoring/treatment, contact/testing, switching counts/durations remain unverified; no individual testing/procedure methods.
- Comparator: Separate assigned surgery/radiotherapy arms. Three-arm randomized superiority comparison, unmasked treatment, independent death committee and ITT are preserved historical descriptions, not complete verification of metastasis/progression adjudication/masking or switching handling.
- Measured outcome: Link original metastasis 9.4% versus 4.7%/5.0% and progression 25.9% versus 10.5%/11.0% to the original grade D question of equivalent metastasis/clinical progression. The 15-year metastasis counts 51/26/27 and cancer deaths 17/545 (3.1%), 12/553 (2.2%), 16/545 (2.9%)/overall P=.53 concern separate endpoints/denominators. Mortality nonsignificance is not equivalence; no new metastasis/progression effects/CI.
- Duration: Separate the 15-year report from the same ProtecT cohort’s 10-year report. Do not add 10-year deaths 8/5/4/metastases 33/13/16 to cumulative 15-year counts. Individual follow-up/censoring, outcomes beyond 15 years or contemporary strategies/other populations remain unverified.
- Questions outside this scope: Changing mortality P=.53 into equivalent metastasis/progression, zero effect or proof of noninferiority; Calculating new RR/HR/differences/CI/individual predictions from 15-year metastasis/progression percentages or original roughly twofold/2.5-fold wording; Adding cumulative 10-year deaths 8/5/4/metastases 33/13/16 and 15-year deaths 17/12/16/metastases 51/26/27 or calculating new interval effects; Repurposing death-committee/ITT/complete follow-up for 1,610/1,643 (98%) as verification of metastasis/progression adjudication, identical denominators or complete observation; Changing monitoring assignment into lifelong untreated exposure without rescue/radical-treatment switching; Generalizing PSA-led ProtecT to contemporary MRI/repeat-biopsy surveillance, other detection populations or individual-treatment selection; Creating unlinked other-population PIVOT/SPCG-4 mortality as direct selected metastasis/progression evidence or new reports; Inheriting original parent values/axes and historical cross-checking/registration/allocation/masking/analysis descriptions as subclaim scores or current clinical-content review/full-text reading; New arithmetic, invented quantities, effects/CI, grades/independence certification or PSA-testing/monitoring/cancer-treatment selection/treatment-replacement instructions

## Checklist items

### N01 · Selected equivalence claim and original grade

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The selected subclaim is equivalent metastasis and clinical progression, grade D, with the note that both were clearly higher with monitoring. Subclaim score/status/axes are absent; parent D34 does not fill the subclaim score.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Subclaim score/status/axes are absent. Mortality nonsignificance is not transferred to equivalent metastasis/progression. Existing content review remains incomplete.
- Reason for missing information: Subclaim score/status/axes are absent. Mortality nonsignificance is not transferred to equivalent metastasis/progression.
- Required materials and conditions: Distinguish selected wording/grade/note from parent mortality verdict
- Materials to obtain first: Original selected question/parent verdict and user correction comments
- Further research: Proposed follow-up research distinguishing each endpoint/comparison specification; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Distinguish selected wording/grade/note from parent mortality verdict should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Distinguish selected wording/grade/note from parent mortality verdict to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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

### N02 · PSA detection, localized cancer and population

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: ProtecT involved 1,643 men aged 50–69 with PSA-detected localized prostate cancer. Do not extend metastasis/progression results to clinically detected cancer or other age/risk populations.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Detailed eligibility, risk/stage distribution, baseline balance, recruitment/exclusions and generalizability remain unverified. Existing content review remains incomplete.
- Reason for missing information: Detailed eligibility, risk/stage distribution, baseline balance, recruitment/exclusions and generalizability remain unverified.
- Required materials and conditions: PSA-detected population, eligibility/risk and baseline characteristics
- Materials to obtain first: Population/risk, recruitment and baseline-characteristic tables
- Further research: Proposed follow-up comparative research specifying population conditions; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for PSA-detected population, eligibility/risk and baseline characteristics should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing PSA-detected population, eligibility/risk and baseline characteristics to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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 Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design
- Related sources: S01

### N03 · Identity of PSA-led monitoring

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original intervention was PSA-led active monitoring. It is not treated as identical to contemporary active surveillance with more MRI and regular repeat biopsy.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Original monitoring testing/switching rules, actual delivery and direct correspondence with contemporary approaches remain unverified. Existing content review remains incomplete.
- Reason for missing information: Original monitoring testing/switching rules, actual delivery and direct correspondence with contemporary approaches remain unverified.
- Required materials and conditions: Original monitoring approach, intervention/testing/switching criteria
- Materials to obtain first: Study monitoring manual and actual delivery/switching records
- Further research: Proposed follow-up research separating monitoring approach from applicability; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Original monitoring approach, intervention/testing/switching criteria should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Original monitoring approach, intervention/testing/switching criteria to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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 labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application
- Related sources: S01

### N04 · Three arms and comparison specifications

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Allocation was monitoring 545, surgery 553 and radiotherapy 545 participants. Do not convert the three arms into a pooled comparator or identical treatment exposure.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Treatment details, adjuvant/rescue care, contact, actual delivery/refusal and arm differences remain unverified. Existing content review remains incomplete.
- Reason for missing information: Treatment details, adjuvant/rescue care, contact, actual delivery/refusal and arm differences remain unverified.
- Required materials and conditions: Arm correspondence and actual monitoring/surgery/radiotherapy treatment
- Materials to obtain first: Arm-specific care/contact, switching and concurrent exposure data
- Further research: Proposed follow-up research distinguishing three comparisons and actual treatment pathways; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Arm correspondence and actual monitoring/surgery/radiotherapy treatment should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Arm correspondence and actual monitoring/surgery/radiotherapy treatment to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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 labels and testing adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed
- Related sources: S01

### N05 · Central randomization and concealment

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original records central-computer allocation. Historical B0 evidence descriptions are not upgraded to allocation-record/concealment review now.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Sequence generation, concealment, implementation exceptions, baseline balance and original protocol remain unread. Existing content review remains incomplete.
- Reason for missing information: Sequence generation, concealment, implementation exceptions, baseline balance and original protocol remain unread.
- Required materials and conditions: Historical allocation descriptions versus actual original-text access
- Materials to obtain first: Original allocation/concealment, baseline tables and protocol
- Further research: Proposed follow-up trial disclosing allocation procedures; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Historical allocation descriptions versus actual original-text access should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Historical allocation descriptions versus actual original-text access to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications are internally designed
- Related sources: S01

### N06 · Masking and endpoint-specific adjudicators

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original records that treatment masking was impossible and causes of death were adjudicated by an independent committee. This is not automatically transferred to complete verification of metastasis/clinical-progression assessment, masking or independent adjudication.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Metastasis/progression adjudicators, masking, testing frequency and committee roles/criteria remain unverified. Existing content review remains incomplete.
- Reason for missing information: Metastasis/progression adjudicators, masking, testing frequency and committee roles/criteria remain unverified.
- Required materials and conditions: Separate cause-of-death committee from metastasis/progression assessment
- Materials to obtain first: Original metastasis/progression adjudication, testing and masking materials
- Further research: Proposed research distinguishing endpoint-specific adjudication and measurement differences; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Separate cause-of-death committee from metastasis/progression assessment should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Separate cause-of-death committee from metastasis/progression assessment to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design
- Related sources: S01

### N07 · 15 years and follow-up range

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Preserve original median 15 years, range 11–21. Do not fill in exactly 15-year observation for everyone or identical event-time/proportion denominators.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Individual follow-up, endpoint assessment windows/censoring, risk populations and visit systems remain unverified. Existing content review remains incomplete.
- Reason for missing information: Individual follow-up, endpoint assessment windows/censoring, risk populations and visit systems remain unverified.
- Required materials and conditions: 15-year analysis, median/range and individual observation duration
- Materials to obtain first: Follow-up/censoring and endpoint-specific risk-population/timing data
- Further research: Proposed research separately reporting time points and actual follow-up duration; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for 15-year analysis, median/range and individual observation duration should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing 15-year analysis, median/range and individual observation duration to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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 adaptations are Chamgap design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation
- Related sources: S01, S02

### N08 · Definition of metastasis events

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Metastasis is a separate clinical endpoint from mortality. Summary numbers are not made equivalent to diagnostic methods/repeated events or all progression events.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Metastasis definition, imaging/adjudication, first/cumulative event handling, baseline-metastasis exclusion and testing frequency remain unverified. Existing content review remains incomplete.
- Reason for missing information: Metastasis definition, imaging/adjudication, first/cumulative event handling, baseline-metastasis exclusion and testing frequency remain unverified.
- Required materials and conditions: Metastasis definition, testing/adjudication, occurrence time and person units
- Materials to obtain first: Metastasis endpoint definitions, adjudication/testing and event data
- Further research: Proposed follow-up research specifying metastasis measurement; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Metastasis definition, testing/adjudication, occurrence time and person units should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Metastasis definition, testing/adjudication, occurrence time and person units to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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 adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 §8.2.2, M15 §15.3.1; internal application
- Related sources: S01, S02

### N09 · 15-year metastasis percentages and cumulative counts

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: In monitoring/surgery/radiotherapy order, original metastasis was 9.4% versus 4.7%/5.0%, with cumulative 15-year counts of 51/26/27. No new percentages, differences/RR/HR or CI.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Exact estimation methods, endpoint-specific valid/risk denominators, CI/models and individual event times remain unverified. Existing content review remains incomplete.
- Reason for missing information: Exact estimation methods, endpoint-specific valid/risk denominators, CI/models and individual event times remain unverified.
- Required materials and conditions: Arm-specific metastasis percentages/counts, original time and denominators
- Materials to obtain first: Metastasis result tables, risk populations and model/CI data
- Further research: Proposed research distinguishing metastasis counts/percentages from estimands; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Arm-specific metastasis percentages/counts, original time and denominators should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Arm-specific metastasis percentages/counts, original time and denominators to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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 adaptations are internally designed; M15 §15.3.1–15.3.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application
- Related sources: S01, S02

### N10 · 15-year clinical-progression percentages

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original clinical progression was monitoring 25.9%, surgery 10.5% and radiotherapy 11.0%. Do not substitute metastasis percentages/cumulative counts or death events.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Progression definitions, component events/overlap, actual counts/denominators and exact models/CI remain unverified. Existing content review remains incomplete.
- Reason for missing information: Progression definitions, component events/overlap, actual counts/denominators and exact models/CI remain unverified.
- Required materials and conditions: Progression definition, arm-specific percentages and distinction from metastasis
- Materials to obtain first: Progression definitions, component events, denominators/results/CI
- Further research: Proposed follow-up research distinguishing metastasis/progression overlap and definitions; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Progression definition, arm-specific percentages and distinction from metastasis should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Progression definition, arm-specific percentages and distinction from metastasis to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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 internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M15 §15.3.1–15.3.3; internal application
- Related sources: S01

### N11 · Metastasis/progression effects and precision

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original interprets metastasis as roughly twice and progression roughly 2.5 times as frequent with monitoring. Historical wording is not converted into new calculations, exact risk ratios/CI or individual predictions.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Exact comparison-specific effects, CI/testing, adjustments/competing-risk models remain unverified. Existing content review remains incomplete.
- Reason for missing information: Exact comparison-specific effects, CI/testing, adjustments/competing-risk models remain unverified.
- Required materials and conditions: Original percentages/interpretation versus exact between-arm effects/CI
- Materials to obtain first: Original effects/CI, comparisons/models and importance thresholds
- Further research: Proposed follow-up research disclosing exact effects and uncertainty; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Original percentages/interpretation versus exact between-arm effects/CI should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Original percentages/interpretation versus exact between-arm effects/CI to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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 adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design
- Related sources: S01

### N12 · Mortality nonsignificance and other endpoints

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Cancer mortality was 17/545 (3.1%), 12/553 (2.2%) and 16/545 (2.9%), overall P=.53. Mortality nonsignificance does not establish equivalent metastasis/progression, zero effect or equivalence.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Comparison-specific mortality effects/CI, equivalence margins and analysis specifications relating to metastasis/progression remain unverified. Existing content review remains incomplete.
- Reason for missing information: Comparison-specific mortality effects/CI, equivalence margins and analysis specifications relating to metastasis/progression remain unverified.
- Required materials and conditions: Separate 15-year cancer-mortality and metastasis/progression results
- Materials to obtain first: Mortality/metastasis/progression-specific results, CI and plans
- Further research: Proposed follow-up research separating endpoint-specific results; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Separate 15-year cancer-mortality and metastasis/progression results should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Separate 15-year cancer-mortality and metastasis/progression results to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap's own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M15 §15.3.1–15.3.3; Chamgap application
- Related sources: S01

### N13 · Cancer mortality, all-cause mortality and competing events

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The parent primary endpoint was definite/probable prostate-cancer mortality. Do not convert it to all-cause/other mortality, functional outcomes or an identical metastasis/progression endpoint.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. All-cause/other-cause death, competing-event handling and censoring/overlap details remain unverified. Existing content review remains incomplete.
- Reason for missing information: All-cause/other-cause death, competing-event handling and censoring/overlap details remain unverified.
- Required materials and conditions: Causes of death versus metastasis/progression competing-event/censoring specifications
- Materials to obtain first: Endpoint/cause-of-death, competing-risk and censoring materials
- Further research: Proposed research separating event-specific competing/censoring processes and effects; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Causes of death versus metastasis/progression competing-event/censoring specifications should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Causes of death versus metastasis/progression competing-event/censoring specifications to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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 a custom design; M08 §8.2.2, M15 §15.3.1; Custom application; M03 §3.2.4; Custom extension boundary
- Related sources: S01

### N14 · 10-year cumulative results

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Original 10-year deaths were 8/5/4 and metastases 33/13/16; 15-year deaths were 17/12/16 and metastases 51/26/27. Do not add the two times or calculate new annual events/changes.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. 10-year endpoints/denominators/CI, progression counts and detailed correspondence between analyses remain unverified. Existing content review remains incomplete.
- Reason for missing information: 10-year endpoints/denominators/CI, progression counts and detailed correspondence between analyses remain unverified.
- Required materials and conditions: Same-cohort 10/15-year counts and time points
- Materials to obtain first: Original 10/15-year results and time/endpoint correspondence
- Further research: Proposed research distinguishing cumulative/time analyses in the same cohort; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Same-cohort 10/15-year counts and time points should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Same-cohort 10/15-year counts and time points to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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/outcome links are an internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed
- Related sources: S01, S02

### N15 · Same trial, two reports and independence

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: S01 Hamdy 2023 at 15 years and S02 Hamdy 2016 at 10 years concern the same ProtecT cohort. Times, three arms, citations/registration and related sheets are not newly added as independent trials/participants.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Unique clinical-trial/participant totals and separate independent-replication counts are not confirmed. Existing content review remains incomplete.
- Reason for missing information: Unique clinical-trial/participant totals and separate independent-replication counts are not confirmed.
- Required materials and conditions: 15/10-year citations and same-participant follow-up
- Materials to obtain first: Report/cohort, registration/protocol relationships and separate-study materials
- Further research: Proposed follow-up independent comparative research on the same endpoint/strategy; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for 15/10-year citations and same-participant follow-up should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing 15/10-year citations and same-participant follow-up to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application
- Related sources: S01, S02

### N16 · Crossover and rescue treatment

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original records many participants later switching to rescue/radical treatment. Monitoring assignment is not converted into lifelong untreated exposure.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Switching counts/timing/reasons, arm-specific actual treatment, adherence and treatment-specific analyses remain unverified. Existing content review remains incomplete.
- Reason for missing information: Switching counts/timing/reasons, arm-specific actual treatment, adherence and treatment-specific analyses remain unverified.
- Required materials and conditions: Separate assigned strategies from actual switching/treatment pathways
- Materials to obtain first: Assigned/actual treatment, switching and rescue-treatment materials
- Further research: Proposed follow-up research separating assigned strategies from actual pathways; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Separate assigned strategies from actual switching/treatment pathways should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Separate assigned strategies from actual switching/treatment pathways to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed
- Related sources: S01

### N17 · ITT strategy estimands

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original records ITT comparison. This is preserved history; no new treatment-specific effects or effects in a never-switching population.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Endpoint-specific ITT populations, switching handling, adjustments/sensitivity and actual-treatment analyses remain unread. Existing content review remains incomplete.
- Reason for missing information: Endpoint-specific ITT populations, switching handling, adjustments/sensitivity and actual-treatment analyses remain unread.
- Required materials and conditions: Assignment-based analysis versus actual-treatment/switching effects
- Materials to obtain first: Original ITT, switching/sensitivity and endpoint-specific models
- Further research: Proposed research distinguishing strategy estimands from actual-treatment estimands; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Assignment-based analysis versus actual-treatment/switching effects should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Assignment-based analysis versus actual-treatment/switching effects to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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 §8.2.2, M15 §15.3.1; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications are internally designed
- Related sources: S01

### N18 · Follow-up completeness and endpoint-specific denominators

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Preserve original follow-up completeness of 1,610/1,643 (98%). Do not fill all-time universal metastasis/progression observation or identical denominators from it, or calculate new missing counts.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Endpoint-specific valid/risk denominators, missingness/withdrawal reasons, times and arm-specific completeness/handling remain unverified. Existing content review remains incomplete.
- Reason for missing information: Endpoint-specific valid/risk denominators, missingness/withdrawal reasons, times and arm-specific completeness/handling remain unverified.
- Required materials and conditions: 1,610/1,643 (98%) versus actual endpoint/risk populations
- Materials to obtain first: Follow-up flow, endpoint/arm denominators and missingness-handling data
- Further research: Proposed research distinguishing observation/risk denominators and missingness; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for 1,610/1,643 (98%) versus actual endpoint/risk populations should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing 1,610/1,643 (98%) versus actual endpoint/risk populations to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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 design; M08 §8.2.2 and M15 §15.3.1; Chamgap application
- Related sources: S01

### N19 · Registration, prespecified hierarchy and composite identifiers

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original evidence-list registration field is ISRCTN20141297 · NCT02044172. Historical matching with the mortality primary endpoint does not replace complete verification of prespecified metastasis/progression analyses.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Registration histories, protocol/SAP, prespecified metastasis/progression hierarchy, amendments/multiplicity plans remain unread. Existing content review remains incomplete.
- Reason for missing information: Registration histories, protocol/SAP, prespecified metastasis/progression hierarchy, amendments/multiplicity plans remain unread.
- Required materials and conditions: Registration IDs, mortality primary endpoint and metastasis/progression hierarchy
- Materials to obtain first: Both registration histories, protocol and SAP
- Further research: Proposed research publicly linking primary/secondary endpoints to actual analysis; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Registration IDs, mortality primary endpoint and metastasis/progression hierarchy should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Registration IDs, mortality primary endpoint and metastasis/progression hierarchy to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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

### N20 · Superiority versus equivalence/noninferiority

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original trial was a three-arm superiority comparison, not a noninferiority trial. Mortality P=.53 is not proof of equivalence and is separated from increased metastasis/progression.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Equivalence/noninferiority margins and corresponding estimands/CI are not presented in preserved materials. Existing content review remains incomplete.
- Reason for missing information: Equivalence/noninferiority margins and corresponding estimands/CI are not presented in preserved materials.
- Required materials and conditions: Testing design, prespecified margins and equivalence-claim scope
- Materials to obtain first: Original design/testing specifications and effect/CI materials
- Further research: Proposed follow-up research distinguishing questions and testing specifications; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Testing design, prespecified margins and equivalence-claim scope should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Testing design, prespecified margins and equivalence-claim scope to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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; internal application; M15 §15.3.1–15.3.3; internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed
- Related sources: S01

### N21 · Metastasis/progression testing and concurrent care

Verification status: Unverified  
Reading scope: Summary read; external material unread

- Current findings: The original records a long-term comparison of three strategies. Do not fill in equal testing frequency, rescue/adjuvant treatment, lifestyle/drug care or absence of their influence on differences.
- Why unverified: Required current information remains unverified in the preserved summary. Arm-specific testing/contact, concurrent treatment, confirmation frequency and analysis-handling details remain unverified. Existing content review remains incomplete.
- Reason for missing information: Arm-specific testing/contact, concurrent treatment, confirmation frequency and analysis-handling details remain unverified.
- Required materials and conditions: Arm-specific testing intensity, concurrent care/treatment and measurement differences
- Materials to obtain first: Testing/concurrent treatment, endpoint adjudication and analysis data
- Further research: Proposed research distinguishing testing/treatment pathways from outcome measurement; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Arm-specific testing intensity, concurrent care/treatment and measurement differences should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Arm-specific testing intensity, concurrent care/treatment and measurement differences to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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, M08 §8.2.2–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed
- Related sources: S01

### N22 · Contemporary surveillance and other-population applicability

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original describes contemporary active surveillance as using more MRI/regular repeat biopsy than ProtecT. Original metastasis/progression rates do not provide contemporary-management or individual-treatment-selection instructions.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Direct comparison with contemporary approaches/populations, long-term results and switching correspondence remain unverified. Existing content review remains incomplete.
- Reason for missing information: Direct comparison with contemporary approaches/populations, long-term results and switching correspondence remain unverified.
- Required materials and conditions: Original PSA-led approach versus contemporary MRI/repeat biopsy and population differences
- Materials to obtain first: Strategy/population definitions, direct comparisons and follow-up data
- Further research: Proposed follow-up research specifying approach and population differences; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Original PSA-led approach versus contemporary MRI/repeat biopsy and population differences should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Original PSA-led approach versus contemporary MRI/repeat biopsy and population differences to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed; M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed
- Related sources: S01

### N23 · PIVOT and SPCG-4 mentions

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original records same-direction PIVOT mortality and SPCG-4 surgery advantage/10% PSA detection. Mortality in clinically detected populations is not combined as a direct comparison/new independent replication of selected metastasis/progression.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Specific citations, populations/denominators, metastasis/progression/CI and direct correspondence remain unlinked. Existing content review remains incomplete.
- Reason for missing information: Specific citations, populations/denominators, metastasis/progression/CI and direct correspondence remain unlinked.
- Required materials and conditions: Other trials’ detection methods, endpoints and directness
- Materials to obtain first: Other-trial originals and detection/endpoint/strategy relationships
- Further research: Proposed follow-up comparative research matching populations/detection methods/endpoints; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Other trials’ detection methods, endpoints and directness should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Other trials’ detection methods, endpoints and directness to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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/outcome links are an internal application; M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed
- Related sources: S01

### N24 · NIHR and MRC support

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original records main NIHR HTA Programme funding and NIHR/MRC long-term-follow-up support. Public funding does not newly certify all support/author relationships or analytical independence.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Supporting institutions’ roles, contracts and other in-kind/analysis/writing/publication support remain unread. Existing content review remains incomplete.
- Reason for missing information: Supporting institutions’ roles, contracts and other in-kind/analysis/writing/publication support remain unread.
- Required materials and conditions: Separate main/long-term-follow-up funding and roles
- Materials to obtain first: Original support/funding, roles and other support
- Further research: Proposed research disclosing support stages and roles; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Separate main/long-term-follow-up funding and roles should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Separate main/long-term-follow-up funding and roles to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.
- Related sources: S01

### N25 · Oxford sponsorship and author relationships

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original records University of Oxford sponsorship. This role does not become commercial-product support, absence of all author COI or an identical role to public funders.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Sponsor responsibilities/authority, author relationships, product/analysis/writing support and original COI remain unread. Existing content review remains incomplete.
- Reason for missing information: Sponsor responsibilities/authority, author relationships, product/analysis/writing support and original COI remain unread.
- Required materials and conditions: Separate study sponsorship from funding/product/COI roles
- Materials to obtain first: Original sponsor, author contributions/COI and support roles
- Further research: Proposed research separately disclosing study roles, support and relationships; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Separate study sponsorship from funding/product/COI roles should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Separate study sponsorship from funding/product/COI roles to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.
- Related sources: S01

### N26 · Functional harms and treatment-specific results

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original records different harms: surgery-related incontinence/erectile effects, radiotherapy bowel/sexual effects and monitoring metastasis/progression. No individual-treatment/implementation instructions or quantitative comparison of all harms.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Exact functional-endpoint definitions, denominators/times/values, collection/adjudication and individual-choice effects remain unverified. Existing content review remains incomplete.
- Reason for missing information: Exact functional-endpoint definitions, denominators/times/values, collection/adjudication and individual-choice effects remain unverified.
- Required materials and conditions: Separate incontinence/erectile/bowel/sexual function from metastasis/progression/mortality
- Materials to obtain first: Function/harm-specific results, definitions and follow-up data
- Further research: Proposed follow-up research separating survival/metastasis/functional harms; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Separate incontinence/erectile/bowel/sexual function from metastasis/progression/mortality should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Separate incontinence/erectile/bowel/sexual function from metastasis/progression/mortality to connect materials needed for the selected question with available materials.
- Application exceptions: Supplements safety-information gaps for the selected subclaim. Metastasis/progression/mortality results or parent caution wording do not yield safety verdicts, harm incidence or new use 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, S02

### N27 · No new treatment-complication reporting at 15 years

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The original records that the 15-year paper reported no new treatment complications after the 10-year analysis. This does not establish no complications or equivalent long-term safety.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. New reporting/collection scope, long-term adverse events, denominators and adjudication/missingness remain unverified. Existing content review remains incomplete.
- Reason for missing information: New reporting/collection scope, long-term adverse events, denominators and adjudication/missingness remain unverified.
- Required materials and conditions: Reporting after 10 years versus actual safety scope
- Materials to obtain first: 10/15-year safety collection and all-complication/follow-up data
- Further research: Proposed research distinguishing reporting scope from actual occurrence/follow-up; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Reporting after 10 years versus actual safety scope should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Reporting after 10 years versus actual safety scope to connect materials needed for the selected question with available materials.
- Application exceptions: Supplements safety-information gaps for the selected subclaim. Metastasis/progression/mortality results or parent caution wording do not yield safety verdicts, harm incidence or new use 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 discrimination is internally designed; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; internal application
- Related sources: S01, S02

### N28 · Original axes, bilingual text, dates, corrections and history

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: Preserve parent D34, B/H/R1/I2/E0/B0/C0, true large-hard-endpoint RCT, two false indicators, empty grade-override reasons and subclaim D/note. Bilingual text, 2026-08-26, empty corrections/deliberation and cross-checking are not completed clinical review now or subclaim axes.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Parent E0/score and mortality-verdict axes do not fill metastasis/progression effects/scores. Existing content review remains incomplete.
- Reason for missing information: Parent E0/score and mortality-verdict axes do not fill metastasis/progression effects/scores.
- Required materials and conditions: Separate parent mortality axes/score from selected subclaim values
- Materials to obtain first: Original corrections, versions and user correction comments
- Further research: Proposed research distinguishing original values/history from new-material scope; no new investigation, calculation or trial was performed in this production.
- Conditions for verification: Relevant originals and analysis scope for Separate parent mortality axes/score from selected subclaim values should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Separate parent mortality axes/score from selected subclaim values to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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

### N29 · Actual summary reading, links and gaps

Verification status: Partly verified  
Reading scope: Summary read; external material unread

- Current findings: The complete preserved summary/citations were used for production and 10/15-year links retained. Original papers, both registrations, protocol, SAP and support/COI remain unread; access and external-link testing were not attempted.
- Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. External original content, exact definitions/CI and actual accessibility remain unverified. Existing content review remains incomplete.
- Reason for missing information: External original content, exact definitions/CI and actual accessibility remain unverified.
- Required materials and conditions: Preserved-summary reading versus external reports/registration/plans access
- Materials to obtain first: Original paper, registration, protocol, SAP and support materials or user comments
- Further research: Proposal for updating while distinguishing actual acquisition/timing/scope; no new investigation, calculation or trial was performed in that production.
- Conditions for verification: Relevant originals and analysis scope for Preserved-summary reading versus external reports/registration/plans access should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
- Why this condition is needed: An application item distinguishing Preserved-summary reading versus external reports/registration/plans access to connect materials needed for the selected question with available materials.
- Application exceptions: Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.
- 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

## Evidence and sources

### S01

Hamdy FC et al. 2023 ProtecT 15-year follow-up

[PubMed](https://pubmed.ncbi.nlm.nih.gov/36912538/)

Materials actually read: Summary read; external material unread  
Findings recorded in the summary: 17/545 (3.1%) versus 12/553 (2.2%) versus 16/545 (2.9%); overall P=.53. Parent D with 34 points. The mortality primary endpoint was null in a superiority comparison. Metastasis was 9.4% versus 4.7%/5.0%, and clinical progression 25.9% versus 10.5%/11.0%, roughly twice and 2.5 times as frequent with monitoring. Fifteen-year prostate-cancer mortality did not differ significantly, but monitoring had much more metastasis/clinical progression.  
Record level: Outcome wording in the stored summary  
Independent replication: S01 Hamdy 2023 at 15 years and S02 Hamdy 2016 at 10 years are cumulative reports of the same ProtecT cohort. Original 1,643 men aged 50–69 with PSA-detected localized cancer, monitoring 545/surgery 553/radiotherapy 545, and complete follow-up for 1,610/1,643 (98%) do not automatically fill endpoint-specific valid/risk denominators. Distinguish 15-year metastasis 9.4% versus 4.7%/5.0%, counts 51/26/27, progression 25.9% versus 10.5%/11.0%, and deaths 17/545, 12/553, 16/545/P=.53. Do not add 10-year deaths 8/5/4/metastases 33/13/16 to 15-year counts. The same people, arms, times, citations, registration and related sheets are not newly added as independent trials/participants. PIVOT/SPCG-4 and contemporary-surveillance differences remain unlinked/scope context, not newly created reports or direct metastasis evidence. Report items are not unique clinical totals.

| 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

Hamdy FC, et al. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy. N Engl J Med. 2016. PMID: 27626136.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/27626136/)

Materials actually read: Summary read; external material unread  
Findings recorded in the summary: Same ProtecT cohort’s 10-year deaths 8/5/4 and metastases 33/13/16, in monitoring/surgery/radiotherapy order. Cumulative 10-year report of the same cohort.  
Record level: Outcome wording in the stored summary  
Independent replication: S01 Hamdy 2023 at 15 years and S02 Hamdy 2016 at 10 years are cumulative reports of the same ProtecT cohort. Original 1,643 men aged 50–69 with PSA-detected localized cancer, monitoring 545/surgery 553/radiotherapy 545, and complete follow-up for 1,610/1,643 (98%) do not automatically fill endpoint-specific valid/risk denominators. Distinguish 15-year metastasis 9.4% versus 4.7%/5.0%, counts 51/26/27, progression 25.9% versus 10.5%/11.0%, and deaths 17/545, 12/553, 16/545/P=.53. Do not add 10-year deaths 8/5/4/metastases 33/13/16 to 15-year counts. The same people, arms, times, citations, registration and related sheets are not newly added as independent trials/participants. PIVOT/SPCG-4 and contemporary-surveillance differences remain unlinked/scope context, not newly created reports or direct metastasis evidence. Report items are not unique clinical totals.

| 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

2026-10-14 · Public page/materials 1.0. Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed.