Rigor Reviewed

Rigor-Reviewed Manuscript

Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial

Name: Adcurare Rigor Record — Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial
Item: Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial
Rating: 96
Author: Adcurare

Attard G, Agarwal N, Graff JN, Sandhu S, Efstathiou E, Özgüroğlu M, Pereira de Santana Gomes AJ, Vianna K, Luo H, Gotto GT, Cheng HH, Kim W, Varela CR, Schaeffer D, Kramer K, Li S, Baron B, Shen F, Mundle SD, McCarthy SA, Olmos D, Chi KN, Rathkopf DE.

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Adcurare Rigor Review — 3.25★ (Adequate), 0 critical, 3 high issues for “Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial”

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 6, 2026

Adcurare Rigor Review

Rigor Reviewed

3.25 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

StatisticsStatistic did not reproduce ×3−1.5★
ReportingData & code availability partially met−0.25★

Model-reported confidence: highReviewer agreement: moderateEngine: 7.6.0Source: full text

Problems surfaced2 types

Reported statistics do not recompute
Data/code availability incomplete

This Adcurare Rigor Review uses AI Rigor Reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

The manuscript reports a well-designed phase 3 trial with rigorous methodology and transparent reporting. The main weakness is the absence of code sharing and minor imprecision in statistical reporting (p-value thresholds, missing data handling).

Three independent rigor evaluations were synthesized; the reviewers largely agreed, with minor divergence on statistical analysis and data code availability (resolved by weighing evidence). Study type is interventional (human RCT). Many checklist items (e.g., antibodies, cell lines) are not applicable.

12 major claims checked against the paper's own evidence: all adequately supported.

Recomputed 10 tests: 7 consistent, 3 inconsistent, 10 via agent-written checks.

Reporting

Eight Dimensions7 pass · 1 warn

The introduction cites multiple prior studies establishing PARP inhibitor efficacy in mCRPC with HRR alterations, the synergy between PARP and androgen receptor inhibition, and the unmet need in mCSPC. It acknowledges limitations of prior work, such as resistance to PARP monotherapy and the shift of androgen receptor pathway inhibitors to earlier disease settings. The hypothesis that PARP inhibition at first-line androgen deprivation could be effective is logically derived from this evidence.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper establishes a clear scientific premise by citing prior work on PARP inhibition in HRR-deficient prostate cancer, the rationale for combining PARP and androgen receptor pathway inhibitors, and the gap in treating castration-sensitive disease.

Evidence

direct quote[Introduction, paragraphs 1-3]

“Loss of BRCA was first shown to sensitize cancers to inhibition of PARP via a process known as synthetic lethality”

direct quote[Introduction, paragraph 3]

“Concurrent inhibition of PARP and androgen receptor signaling may be synergistic”

direct quote[Introduction, paragraph 4]

“We therefore aimed to evaluate whether the combination of PARP inhibition and an androgen receptor pathway inhibitor at response to first-line androgen deprivation (castration-sensitive prostate cancer) would be effective.”

PASSReviewer 2· 95% conf

The paper establishes a clear scientific premise by citing prior research on PARP inhibition in HRR-deficient prostate cancer, the rationale for combining PARP and androgen receptor pathway inhibitors, and the need for earlier intervention in mCSPC.

Evidence

direct quote[Introduction, paragraph 1-4]

“Loss of BRCA was first shown to sensitize cancers to inhibition of PARP via a process known as synthetic lethality”

direct quote[Introduction, paragraph 3]

direct quote[Introduction, paragraph 2]

“Despite the efficacy ... resistance commonly occurs, often after emergence of secondary alterations in BRCA2 that restore HRR function”

PASSReviewer 3· 95% conf

The scientific premise is well-established, citing prior work on PARP inhibition in prostate cancer, the rationale for combining PARP and androgen receptor pathway inhibitors, and the gap in treating HRR-deficient mCSPC.

Evidence

direct quote[Introduction, paragraph 1–3]

“Although most clinical studies confirm BRCA1/BRCA2 loss cancers as sensitive, other genes biologically involved in HRR have been included in clinical trials for metastatic prostate cancer relapsing after castration (metastatic castration-resistant prostate cancer, mCRPC), with variable levels of efficacy.”

direct quote[Introduction, paragraph 3]

“Concurrent inhibition of PARP and androgen receptor signaling may be synergistic.”

direct quote[Introduction, paragraph 4]

Randomization was performed using permuted block randomization via an interactive web system, with stratification by HRR gene, prior docetaxel, and metastases volume. The trial is double-blind, with blinding maintained after progression for overall survival follow-up. A power analysis is provided for the primary endpoint and key subgroups. Inclusion/exclusion criteria are detailed in the methods and protocol. The hierarchical graphical testing approach controls the family-wise type I error rate. For a human RCT, replicate_distinction, controls (wet-lab), and independent_replication are not applicable; outlier_handling is mapped to the analysis population (ITT) and missing data approach (data-as-observed), which is reported but not fully pre-specified for missing data handling.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingINADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study design is rigorous for a phase 3 clinical trial: randomized, double-blind, placebo-controlled, with a clear randomization method, stratification factors, and a pre-specified hierarchical testing procedure. Power analysis and inclusion/exclusion criteria are reported.

Evidence

direct quote[Methods, Trial design and participants; Methods, Trial treatment]

“Randomization was done using permuted block randomization managed via an interactive web randomization system.”

direct quote[Results, Secondary endpoints; Methods, Trial design and participants]

“Double-blinding prior to radiographic progression has been maintained to allow ongoing follow-up of overall survival.”

direct quote[Methods, Statistical analysis]

“It was estimated that approximately 692 patients were to be randomized to observe the 261 radiographic progression events or deaths required to provide 91% power to detect a hazard ratio of 0.64 at a two-sided significance level of 0.02475 for the final analysis”

PASSReviewer 2· 90% conf

The study design is rigorous for a phase 3 clinical trial: randomization and blinding are described, the analysis population and stratification are pre-specified, and a formal power analysis is provided.

Evidence

direct quote[Methods, Trial design and participants]

“Randomization was done using permuted block randomization managed via an interactive web randomization system.”

direct quote[Methods, Statistical analysis]

direct quote[Methods, Participants]

“Eligible male patients were aged 18 years or older, had an ECOG performance status score of 0–2 and had at least one deleterious HRR gene alteration on central testing”

PASSReviewer 3· 95% conf

The study design is rigorous: a randomized, double-blind, placebo-controlled phase 3 trial with pre-specified analyses, stratification, centralized randomization, and a sample size calculation.

Evidence

direct quote[Methods, Trial design and participants; Trial treatment]

“Randomization was done using permuted block randomization managed via an interactive web randomization system.”

direct quote[Methods, Trial design and participants]

“AMPLITUDE is an ongoing randomized, phase 3, double-blind, placebo-controlled trial”

direct quote[Methods, Statistical analysis]

Sex is reported (all male, as expected for prostate cancer). Age is reported with median, range, and by group. Demographics are comprehensively reported including race, region, ECOG performance status, Gleason score, metastatic stage, and PSA levels. A justification for a single-sex study is not required as this is a disease-specific trial in prostate cancer. Species/strain/housing are not applicable to this human trial.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Key biological variables for a human clinical trial are well reported: age, sex (all male), race, ECOG performance status, Gleason score, metastatic volume, and PSA levels are provided in baseline tables. Species/strain and housing conditions are not applicable.

Evidence

direct quote[Results, Table 1]

“Median age (range), years | 68 (40–88) | 67 (40–92)”

direct quote[Results, Table 1]

“Metastatic disease volume at start of androgen deprivation therapy, n (%) | High | 269 (77.3) | 271 (77.9)”

PASSReviewer 2· 100% conf

The study adequately reports the key biological variables applicable to a human clinical trial: sex, age, and comprehensive demographics.

Evidence

direct quote[Table 1, Results]

“Median age (range), years: 68 (40–88) in niraparib arm, 67 (40–92) in abiraterone arm”

direct quote[Table 1]

“Race, n (%): White 246 (70.7) | Asian 77 (22.1) | Black or African American 18 (5.2)”

PASSReviewer 3· 90% conf

Key biological variables (age, disease characteristics, HRR gene alterations) are well reported; sex is not applicable as the study enrolled only males (prostate cancer).

Evidence

direct quote[Table 1]

“Median age (range), years: 68 (40–88) [niraparib group]; 67 (40–92) [control group]”

direct quote[Table 1]

“Race, n (%): White 246 (70.7), Asian 77 (22.1), Black or African American 18 (5.2), Other 3 (0.9), Not reported/unknown 4 (1.1)”

direct quote[Methods, Participants]

“Eligible male patients were aged 18 years or older”

The methods state that the protocol was approved by the review board at each participating institution and health authorities in every participating country. The trial was conducted in accordance with ICH-GCP and the Declaration of Helsinki. All patients provided written informed consent. A named ethics body is not explicitly listed in the paper text, but the statement of approval by 'the review board at each participating institution' is standard for a multinational trial and is considered adequate. The trial is registered at ClinicalTrials.gov (NCT04497844).

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approvals are adequately reported: the protocol was approved by review boards at each participating institution, the trial was conducted in accordance with ICH-GCP and the Declaration of Helsinki, and written informed consent was obtained from all patients.

Evidence

direct quote[Methods, Trial design and participants]

“The protocol was approved by the review board at each participating institution and health authorities in every participating country”

direct quote[Methods, Trial design and participants]

“The trial was conducted in accordance with the International Counsel for Harmonisation guidelines for Good Clinical Practice and the principles of the Declaration of Helsinki.”

direct quote[Methods, Trial design and participants]

“All patients provided written informed consent.”

PASSReviewer 2· 95% conf

Ethical approvals are adequately described: a statement of ethics committee approval, informed consent, and compliance with regulatory guidelines are all present.

Evidence

direct quote[Methods, Trial design and participants]

“The protocol was approved by the review board at each participating institution and health authorities in every participating country”

direct quote[Methods, Trial design and participants]

“All patients provided written informed consent.”

direct quote[Methods, Trial design and participants]

“The trial was conducted in accordance with the International Counsel for Harmonisation guidelines for Good Clinical Practice and the principles of the Declaration of Helsinki.”

PASSReviewer 3· 95% conf

Ethical approvals are adequately reported: IRB approval at each site, informed consent obtained, and regulatory compliance (ICH-GCP, Declaration of Helsinki) stated.

Evidence

direct quote[Methods, Trial design and participants]

“The protocol was approved by the review board at each participating institution and health authorities in every participating country; the protocol can be found in the [Supplementary Information].”

direct quote[Methods, Trial design and participants]

“All patients provided written informed consent.”

direct quote[Methods, Trial design and participants]

“The trial was conducted in accordance with the International Counsel for Harmonisation guidelines for Good Clinical Practice and the principles of the Declaration of Helsinki.”

The investigational products are clearly identified: niraparib (200 mg), abiraterone acetate (1000 mg), and prednisone (5 mg) with dosing regimen. The central testing assays are named with vendors (Foundation Medicine, Invitae). Statistical software (Medidata, East, SAS) with versions is reported. Antibodies, cell lines, mycoplasma testing, and organisms are not applicable for this human drug trial. Reagents_identified is scored against the investigational products and is adequate.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Key resources for a drug trial are adequately identified: the investigational products (niraparib, abiraterone acetate, prednisone) are named with doses and regimen. The central assays (FoundationOne CDx, FoundationOne Liquid CDx, Invitae Multi-Cancer Panel) are identified with vendors. Statistical software versions are reported.

Evidence

direct quote[Methods, Trial treatment]

“Patients were randomly assigned in a 1:1 ratio to receive a dual-action tablet of niraparib (200 mg) and abiraterone acetate (1,000 mg) plus prednisone (5 mg) orally once daily”

direct quote[Methods, Participants]

“at least one deleterious HRR gene alteration on central testing of tumor tissue (FoundationOne CDx; Foundation Medicine), plasma (FoundationOne Liquid CDx; Foundation Medicine) or germline (Invitae Multi-Cancer Panel; Invitae).”

direct quote[Methods, Statistical analysis]

“Medidata version 2024.2.0 was used for data collection; East version 6.5 was used for sample size calculations; and SAS version 9.4 was used for data analyses.”

PASSReviewer 2· 90% conf

Key investigational products and software are identified; the study as a drug trial reports its investigational product (niraparib/abiraterone/prednisone) adequately.

Evidence

direct quote[Methods, Trial treatment]

“Patients were randomly assigned ... to receive a dual-action tablet of niraparib (200 mg) and abiraterone acetate (1,000 mg) plus prednisone (5 mg) orally once daily”

direct quote[Methods, Statistical analysis]

“SAS version 9.4 was used for data analyses.”

PASSReviewer 3· 90% conf

The investigational drug (niraparib) and comparator (abiraterone, placebo) are adequately identified; software tools are identified; other wet-lab resources are not applicable.

Evidence

direct quote[Methods, Trial treatment]

“Patients were randomly assigned in a 1:1 ratio to receive a dual-action tablet of niraparib (200 mg) and abiraterone acetate (1,000 mg) plus prednisone (5 mg) orally once daily (niraparib and abiraterone group) or matched placebo and abiraterone acetate tablets plus prednisone (abiraterone group)”

direct quote[Methods, Statistical analysis]

“Medidata version 2024.2.0 was used for data collection; East version 6.5 was used for sample size calculations; and SAS version 9.4 was used for data analyses.”

The primary analysis uses stratified log-rank tests and Cox proportional hazards models, which are named. Exact p-values (e.g., P < 0.0001, P = 0.0001) and 95% confidence intervals are reported for all key endpoints. Effect sizes (hazard ratios) are provided with CIs. Statistical software is identified. Data presentation includes Kaplan-Meier curves with number at risk, forest plots, and baseline tables with per-group n. For a large clinical trial with time-to-event endpoints, assumptions_verified is adequate as the Cox model's proportional hazards assumption is standard and not explicitly tested but is a design consideration. Mathematical_plausibility is not applicable for time-to-event data.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Statistical analysis is rigorous: tests are named (stratified log-rank, Cox proportional hazards), exact p-values and confidence intervals are reported, effect sizes (hazard ratios) with CIs are provided, software is identified, and data presentation includes Kaplan-Meier curves and forest plots. Assumptions are handled by design (Cox model). Mathematical plausibility is not applicable for time-to-event data with large N.

Evidence

direct quote[Results, Efficacy: primary endpoint]

“hazard ratio = 0.52 (95% confidence interval: 0.37–0.72); P < 0.0001”

direct quote[Methods, Statistical analysis]

“For time-to-event variables, the Kaplan−Meier method, stratified Cox proportional hazards model and stratified log-rank test were used”

direct quote[Results, Figures 2 and 3]

“Kaplan−Meier estimates of investigator-assessed radiographic progression-free survival”

WARNReviewer 2· 80% conf

Statistical methods are generally well-described (tests named, software identified, data presentation adequate), but exact p-values are not always reported (often reported as '<0.0001' or '0.0001'), and effect sizes are reported as hazard ratios with CIs, but with limited additional precision.

Evidence

direct quote[Methods, Statistical analysis]

“For time-to-event variables, the Kaplan−Meier method, stratified Cox proportional hazards model and stratified log-rank test were used”

direct quote[Results, Efficacy: primary endpoint]

“P < 0.0001”

direct quote[Results, Efficacy: primary endpoint]

“hazard ratio = 0.52 (95% confidence interval: 0.37–0.72)”

PASSReviewer 3· 90% conf

Statistical analysis is robust: pre-specified hierarchical testing, named tests (stratified log-rank, Cox models), exact p-values, effect sizes with CIs, and software identified. Some minor imprecision (thresholds like P < 0.0001) but acceptable.

Evidence

direct quote[Methods, Statistical analysis]

“For time-to-event variables, the Kaplan–Meier method, stratified Cox proportional hazards model and stratified log-rank test were used to estimate the medians, hazard ratios and their associated 95% confidence intervals and P values.”

direct quote[Results, Efficacy: primary endpoint]

“In the first hierarchical test for efficacy, in the BRCA subgroup, treatment with niraparib and abiraterone resulted in significant improvement... (hazard ratio = 0.52 (95% confidence interval: 0.37–0.72); P < 0.0001)”

direct quote[Methods, Statistical analysis]

The data availability statement names the YODA project as the access route for de-identified participant-level data, which is adequate for a clinical trial with patient-level data. Repository deposit and accession numbers are not applicable for identifiable patient-level data, but the trial may have generated non-identifiable data (e.g., sequencing data) that could be deposited; none are reported. Code sharing is not reported; the statistical analysis used standard software (SAS), but custom code for analyses is not mentioned. The statement is adequate for the primary data type, but the lack of code sharing and potential for depositable non-identifiable data leads to a 'warn' status.

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositN/A

data availability statementADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 90% conf

A data availability statement is present and describes a managed access route via the YODA project, which is adequate for patient-level data. However, no code sharing is reported, and no repository deposit or accession numbers are provided for non-identifiable data.

Evidence

direct quote[Data availability section]

“As noted on this site, requests for study data access can be submitted through the Yale Open Data Access (YODA) project site at http://yoda.yale.edu .”

absence[Data availability section]

No code sharing is reported.

PASSReviewer 2· 85% conf

A data availability statement is present and concrete, describing a managed-access platform (YODA) for deidentified participant data, which is standard for this type of trial.

Evidence

direct quote[Data availability section]

“Janssen Pharmaceutical Companies of Johnson & Johnson’s data sharing policy is available at https://www.janssen.com/clinical-trials/transparency . As noted on this site, requests for study data access can be submitted through the Yale Open Data Access (YODA) project site at http://yoda.yale.edu .”

WARNReviewer 3· 85% conf

A data availability statement is provided with a concrete access route (YODA project), which is adequate for patient-level data. However, code sharing is not reported, and no repository deposit or accession numbers are provided for the primary data.

Evidence

direct quote[Data availability]

“As noted on this site, requests for study data access can be submitted through the Yale Open Data Access (YODA) project site at http://yoda.yale.edu”

absence[Data availability]

No code sharing statement found.

Methods are comprehensive, including trial design, participants, procedures, endpoints, and statistical analysis. The trial is registered at ClinicalTrials.gov with identifier NCT04497844. A reporting summary is linked. Limitations are explicitly discussed in the Discussion section, including the small size of individual gene subgroups, lack of formal crossover, and the immature overall survival data. Conclusions are proportional, noting the benefit in BRCA subgroups and the need for further follow-up. Funding (Johnson & Johnson) and conflicts of interest are disclosed in detail.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Reporting is transparent: methods are detailed, the trial is registered (NCT04497844), a reporting summary is linked, limitations are discussed, conclusions are proportional, and funding/COI are disclosed.

Evidence

direct quote[Abstract; Methods, Trial design and participants]

“ClinicalTrials.gov identifier: NCT04497844”

direct quote[Discussion, paragraph 6]

“Our study has some limitations. Only the BRCA and HRR effector gene subgroups were powered for formal statistical testing”

direct quote[Acknowledgements; Competing interests]

“This study was sponsored by Johnson & Johnson.”

PASSReviewer 2· 90% conf

The manuscript is comprehensively reported: methods are detailed, limitations are discussed, conclusions are proportional, and funding/COI are stated. A trial registration number is provided.

Evidence

direct quote[Abstract, Methods]

“ClinicalTrials.gov identifier: NCT04497844”

direct quote[Discussion, paragraph 6]

“Only the BRCA and HRR effector gene subgroups were powered for formal statistical testing, as the number of patients in each of the other seven individual gene subgroups was too small.”

direct quote[Competing interests section]

“This study was sponsored by Johnson & Johnson.”

PASSReviewer 3· 90% conf

Reporting transparency is good: methods are detailed, trial is registered, CONSORT diagram provided, limitations discussed, conclusions are proportional, and funding/COI are reported.

Evidence

direct quote[Abstract; Methods, Trial design and participants]

“ClinicalTrials.gov identifier: NCT04497844”

direct quote[Discussion, paragraph 7]

“Our study has some limitations. Only the BRCA and HRR effector gene subgroups were powered for formal statistical testing, as the number of patients in each of the other seven individual gene subgroups was too small.”

paraphrase[Results, Fig. 1]

“A CONSORT flow diagram shows patient screening, randomization, and follow-up.”

5 copyedit issues flagged: mostly consistency, clarity, other.

Checked 45 references: 43 verified — 2 not checked.

Reproducibility

2 data/code links checked; 2 live.

Registered (5 IDs: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Adcurare Rigor Action ItemsFinal pass before journal submission

Ready after minor edits: the manuscript is methodologically sound, but adding a code sharing statement, clarifying missing data handling, and fixing a few copyedit errors will strengthen the submission and address potential reviewer concerns.

1.
HIGHdata code
Add a code sharing statement to the Data availability section: provide a link to a public repository (e.g., GitHub, Zenodo) with the custom SAS analysis code, or state that code is available upon request from the corresponding author.
No analysis code is currently reported; sharing code enhances reproducibility and is expected by many journals.
2.
HIGHreporting
In the Methods, Statistical analysis section, clarify the handling of missing data beyond the 'data-as-observed' approach; specify whether a complete-case or available-case analysis was used and describe any sensitivity analyses.
The current description is vague and was flagged by both a reviewer and the copyedit pass; clearer reporting strengthens the analysis credibility.
3.
HIGHcopyedit
In Methods, Trial design and participants, correct 'International Counsel for Harmonisation' to 'International Council for Harmonisation' (ICH).
The current phrasing is a misspelling of the standard organization name.
4.
MEDIUMstatistics
In Results, provide exact p-values (e.g., P=0.00012) instead of inequality values like P < 0.0001 where possible, or report them in the supplementary materials.
Exact p-values allow readers to assess the strength of evidence more precisely, though thresholds are standard for very small values.
5.
MEDIUMstatistics
In Methods, Statistical analysis, add a brief verification of the proportional hazards assumption for the Cox models (e.g., a test or scaled Schoenfeld residuals plot in the supplementary materials).
While not always required, verifying this assumption would address a reviewer concern and improve analytic rigor.
6.
MEDIUMreporting
In Methods, Trial design and participants, provide more detailed description of blinding procedures: specify who was blinded (patients, investigators, outcomes assessors) and how blinding was maintained (e.g., matching placebos).
The current description is brief; fuller details help confirm internal validity.
7.
MEDIUMstatistics
In Results, report effect sizes for secondary endpoints (e.g., time to PSA progression, overall survival at interim) with confidence intervals consistently in the main text, not only p-values.
Ensures uniform reporting of effect precision across all outcomes.
8.
MEDIUMdata code
Consider depositing de-identified genomic sequencing data from the central assays (FoundationOne CDx, etc.) in a public repository such as dbGaP or EGA, and cite the accession number in the Data availability section.
Enables data reuse for validation and secondary research, aligning with genomic data sharing best practices.
9.
MEDIUMreporting
In Results, Secondary endpoints, rephrase the long sentence about subsequent treatments in the abiraterone group for clarity (see copyedit suggestion).
Improves readability and avoids potential misinterpretation.
10.
LOWreporting
In Results, add a CONSORT flow diagram with detailed reasons for screen failures and exclusions (Figure 1 may already be present but ensure it is fully detailed).
Provides complete transparency about patient flow, a standard for RCTs.
11.
LOWreporting
In Methods, Participants, consider specifying 'deleterious or suspected deleterious' instead of just 'deleterious' for HRR gene alterations, if applicable.
Aligns with common trial terminology and avoids ambiguity about pathogenicity classification.
12.
LOWcopyedit
In Results, Table 1, ensure the note about percentages not summing to 100 due to rounding is clear; add a statement if multi-answer options apply.
Standard practice for categorical data presentation.
13.
LOWreporting
In Results, for patient-reported outcomes (FACT-P), consider reporting the minimal clinically important difference (MCID) to help interpret clinical significance.
Helps readers assess whether changes are clinically meaningful, not just statistically significant.

Full text (59,121 chars)Analyzed: Jul 6, 2026

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Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial

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DOI

10.1038/s41591-025-03961-8

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