Rigor Reviewed

Rigor-Reviewed Manuscript

Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial.

Name: Adcurare Rigor Record — Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial.
Item: Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial.
Rating: 96
Author: Adcurare

Parker CC, Kynaston H, Cook AD, Clarke NW, Catton CN, Cross WR, Petersen PM, Persad RA, Pugh CA, Saad F, Logue J, Payne H, Bower LC, Brawley C, Rauchenberger M, Barkati M, Bottomley DM, Brasso K, Chung HT, Chung PWM, Conroy R, Falconer A, Ford V, Goh CL, Heath CM, James ND, Kim-Sing C, Kodavatiganti R, Malone SC, Morris SL, Nabid A, Ong AD, Raman R, Rodda S, Wells P, Worlding J, Parulekar WR, Parmar MKB, Sydes MR, RADICALS investigators

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Adcurare Rigor Review — 4★ (Strong), 0 critical, 6 high issues for “Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial.”

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 7, 2026

Adcurare Rigor Review

Rigor Reviewed

4 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern−0.5★
ReportingData & code availability partially met−0.25★
LinksLink inconsistent with the paper−0.25★

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

Problems surfaced3 types

Data/code link contradicts the paper
Data/code availability incomplete
Internal contradictions in the reported numbers

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 paper presents a well-conducted phase 3 RCT with rigorous statistical methods and transparent reporting. The main rigor gaps are in ethical approvals (vague statement), key resources (no manufacturer or software named), and data/code sharing (no code). A copyedit issue with an implausible percentage in Table 1 needs correction. The scientific premise, study design, and statistical analysis are all rated pass.

Evaluation based on full-text review of the manuscript and supplementary materials. All 8 dimensions were applicable. Statistical verification checked 12 tests; all were consistent. No retracted or missing references were found. The reviewers agreed on most dimensions, with minor divergence on biological variables (reviewer 1 gave fail, reviewers 2/3 gave pass) and key resources (reviewer 1 gave fail, reviewers 2/3 gave pass); these were resolved by weighing the evidence.

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

Recomputed 12 tests: 12 consistent, 0 inconsistent, 12 via agent-written checks.

1 integrity concern flagged (0 high).

Reporting

Eight Dimensions7 pass · 1 warn

Prior work is cited (RTOG 0534, GETUG-AFU 16, RTOG 9601) and the gap in comparing ADT durations is identified. The hypothesis follows logically from the evidence. The paper does not discuss specific limitations of previous studies or how they are mitigated, but this is a minor omission.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The scientific premise is well established, with adequate citation of prior work and a clear rationale for the hypothesis. However, limitations of prior research are not explicitly addressed beyond noting the gap in the literature.

Evidence

direct quote[Introduction, paragraph 1]

“Multiple randomised controlled trials have compared different durations of ADT in patients having primary radical radiotherapy, who have not had previous radical prostatectomy. Improved long-term clinical outcomes have been observed with more extended durations of ADT, particularly in those with high-risk disease. Radiotherapy is also commonly used after radical prostatectomy, but only three phase 3 randomised controlled trials in this setting have assessed the addition of ADT, and none have compared different durations of ADT.”

direct quote[Introduction, paragraph 2]

“In developing the RADICALS-HD trial in 2006, we hypothesised that long-course ADT would be more effective than short-course ADT in people receiving postoperative radiotherapy.”

absence[Introduction]

Limitations of prior research are not explicitly addressed beyond noting the gap.

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific premise by citing prior trials of ADT with radiotherapy, noting the gap in evidence for ADT duration in the postoperative setting, and providing a logical rationale for the hypothesis.

Evidence

direct quote[Introduction, paragraph 1]

“Radiotherapy is also commonly used after radical prostatectomy, but only three phase 3 randomised controlled trials in this setting have assessed the addition of ADT, and none have compared different durations of ADT.”

direct quote[Introduction, paragraph 2]

“In developing the RADICALS-HD trial in 2006, we hypothesised that long-course ADT would be more effective than short-course ADT in people receiving postoperative radiotherapy.”

direct quote[Introduction, paragraph 2]

“Given the results of a subgroup analysis of RTOG 9601 in 2020, we also wanted to assess any benefit from long-course versus short-course ADT with respect to comorbidity and PSA levels at the time of radiotherapy.”

PASSReviewer 3· 95% conf

The paper clearly establishes the scientific premise by citing prior trials of ADT with primary radiotherapy and the few trials in the postoperative setting, and provides a logical rationale for comparing ADT durations.

Evidence

direct quote[Introduction, paragraph 1]

direct quote[Introduction, paragraph 2]

“In developing the RADICALS-HD trial in 2006, we hypothesised that long-course ADT would be more effective than short-course ADT in people receiving postoperative radiotherapy.”

direct quote[Introduction, paragraph 2]

Randomization was centralised via minimisation with a random element, stratified by multiple factors. The unit of randomization is the patient. An a priori power analysis is reported. Inclusion/exclusion criteria are clearly defined. The analysis follows intention-to-treat, addressing missing data. The open-label design is stated but not justified.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsINADEQUATE

outlier handlingADEQUATE

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, with adequate randomization, power analysis, inclusion/exclusion criteria, and intention-to-treat analysis. Blinding was not performed (open-label) but was stated, although no rationale was provided.

Evidence

direct quote[Methods, Randomisation and masking]

“Randomisation was achieved centrally by the method of minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned ADT type.”

direct quote[Methods, Statistical analysis]

“Based on 300 metastasis-free survival events from the 1523 participants, this revised design had 80% power with two-sided 5% α to detect an increase in 10-year metastasis-free survival from 75% to 81% (HR 0·72).”

direct quote[Methods, Randomisation and masking]

“The allocated treatment was open label.”

PASSReviewer 2· 95% conf

The study design is rigorous for a phase 3 clinical trial, with central randomisation using minimisation, a pre-specified power analysis, clear inclusion/exclusion criteria, and intention-to-treat analysis. Blinding was not feasible (open-label), which is acknowledged.

Evidence

direct quote[Methods, Randomisation and masking]

direct quote[Methods, Statistical analysis]

direct quote[Methods, Randomisation and masking]

“The allocated treatment was open label.”

PASSReviewer 3· 95% conf

The study design is rigorous: a multicentre, randomised controlled trial with central randomisation using minimisation, a pre-specified power analysis, clear inclusion/exclusion criteria, and intention-to-treat analysis. Blinding was not feasible (open-label), which is acknowledged.

Evidence

direct quote[Methods, Randomisation and masking]

“The allocated treatment was open label.”

direct quote[Methods, Statistical analysis]

Age, PSA, Gleason score, T stage, and Charlson Comorbidity Index are reported in Table 1. The study population is entirely male, which is appropriate for prostate cancer, so a justification for single-sex is not required. The paper explicitly states that race and ethnicity data were not collected, which is a limitation but is transparently reported. Species/strain/source and housing conditions are not applicable to a human trial.

Sub-criteria

demographicsINADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

FAILReviewer 1· 70% conf

Sex is not explicitly reported (though implied by the disease), age is reported, but weight, health status, and race/ethnicity are not reported. A scientific justification for single-sex enrollment is not provided.

Evidence

direct quote[Results, paragraph 1]

“Between Jan 30, 2008, and July 7, 2015, 1523 patients (median age 65 years, IQR 60–69) were randomly assigned...”

direct quote[Results, paragraph 1]

“Data on race and ethnicity were not collected.”

absence[Table 1]

Weight and health status (e.g., Charlson Comorbidity Index) are not reported in the baseline table.

PASSReviewer 2· 90% conf

Key biological variables for a human trial are well reported, including age, PSA levels, Gleason score, T stage, and comorbidities. Sex is reported (all male, as expected for prostate cancer). Race/ethnicity data were not collected, which is acknowledged as a limitation.

Evidence

direct quote[Results, paragraph 1]

“The median age of participants was 65 years (IQR 60–69); 1407 (93%) had a Gleason score of 7 or higher and 461 (30%) had stage T3b disease or higher.”

direct quote[Discussion, paragraph 6]

“The trial opened around 15 years ago, and race and ethnicity data were not routinely recorded in UK-led trials at that time.”

paraphrase[Results, paragraph 1]

“The study enrolled patients with prostate cancer, all of whom are male.”

PASSReviewer 3· 90% conf

Key biological variables (age, PSA, Gleason score, T stage) are well reported in Table 1. Sex is reported (all male, as expected for prostate cancer). Race/ethnicity data were not collected, which is acknowledged as a limitation.

Evidence

direct quote[Results, paragraph 1 and Table 1]

“The median age of participants was 65 years (IQR 60–69); 1407 (93%) had a Gleason score of 7 or higher and 461 (30%) had stage T3b disease or higher.”

direct quote[Results, paragraph 1]

“Data on race and ethnicity were not collected.”

direct quote[Methods, Statistical analysis]

“Two prespecified subgroup analyses were planned, by pre-radiotherapy PSA level and by Charlson Comorbidity Index score.”

The paper states 'Appropriate ethical review was in place for each participating country (appendix p 8).' and 'All participants gave written informed consent.' While the specific ethics committee names are not in the main text, they are referenced in the appendix. The trial is registered with ISRCTN and ClinicalTrials.gov. Regulatory compliance is implied through the statement of ethical review and consent.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 90% conf

Informed consent is adequately reported, but the ethics approval statement is vague (no named ethics body) and regulatory compliance is not explicitly stated.

Evidence

direct quote[Methods, Study design and participants]

“Appropriate ethical review was in place for each participating country (appendix p 8).”

direct quote[Methods, Study design and participants]

“All participants gave written informed consent.”

absence[Methods, Study design and participants]

No explicit statement of regulatory compliance (e.g., Declaration of Helsinki) is present.

PASSReviewer 2· 95% conf

Ethical approvals are adequately reported. The paper states that appropriate ethical review was in place for each participating country, and all participants gave written informed consent. The trial is registered.

Evidence

direct quote[Methods, Study design and participants]

“Appropriate ethical review was in place for each participating country (appendix p 8).”

direct quote[Methods, Study design and participants]

“All participants gave written informed consent.”

direct quote[Methods, Study design and participants]

“This study is registered with the ISRCTN registry, ISRCTN40814031, and with ClinicalTrials.gov (https://clinicaltrials.gov/) , NCT00541047 .”

PASSReviewer 3· 95% conf

Ethical approval is stated, informed consent was obtained, and regulatory compliance is mentioned. The paper states that appropriate ethical review was in place for each participating country and that all participants gave written informed consent.

Evidence

direct quote[Methods, Study design and participants]

“Appropriate ethical review was in place for each participating country (appendix p 8).”

direct quote[Methods, Study design and participants]

“All participants gave written informed consent.”

The paper describes the ADT options (gonadotrophin-releasing hormone analogue, bicalutamide, degarelix) with dosing schedules. This is adequate for a drug trial. The statistical software is not explicitly named in the main text, but the analysis methods are described. Antibodies, cell lines, mycoplasma testing, and organisms are not applicable to this clinical trial. The paper does not mention a specific software package (e.g., SAS, R) in the main text, which is a minor gap.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedINADEQUATE

Per reviewer (3) — the votes behind the verdict

FAILReviewer 1· 80% conf

The investigational drugs are named with dose and regimen, but manufacturer/source are not provided. Statistical software is not identified. No other biological resources apply.

Evidence

direct quote[Methods, Procedures]

“ADT was given with local choice of a subcutaneous gonadotrophin-releasing hormone analogue, supplemented by 3 weeks of an oral anti-androgen started 1 week before the first gonadotrophin-releasing hormone analogue administration. Monthly injections were recommended in the 6 months group and 3-monthly injections were encouraged in the 24 months group. Outside Canada, daily bicalutamide monotherapy 150 mg or monthly subcutaneous degarelix (with nationally approved dosing) were acceptable alternatives.”

absence[Methods, Statistical analysis]

Statistical software is not identified.

PASSReviewer 2· 90% conf

The investigational product (ADT) is adequately identified with its class and administration route. The software used for analysis is not explicitly named in the main text, but the statistical methods are described. Other wet-lab resources are not applicable.

Evidence

direct quote[Methods, Procedures]

absence[Methods, Statistical analysis]

Statistical software is not explicitly named in the main text.

PASSReviewer 3· 90% conf

The investigational product (ADT) is well described: types (GnRH analogue, bicalutamide, degarelix), doses, and schedules are specified. Software tools (SAS, R) are not explicitly named but the statistical analysis plan is referenced. No antibodies, cell lines, or organisms are used.

Evidence

direct quote[Methods, Procedures]

“Outside Canada, daily bicalutamide monotherapy 150 mg or monthly subcutaneous degarelix (with nationally approved dosing) were acceptable alternatives.”

direct quote[Methods, Statistical analysis]

“The full statistical analysis plan is published elsewhere and is summarised here.”

Tests are named (log-rank, Cox regression, competing risks, restricted mean survival time). Proportional hazards assumption is tested (Grambsch–Therneau test). Exact p-values and 95% CIs are reported for all primary and secondary outcomes. Data presentation includes Kaplan-Meier curves and tables with n and events. Software is not specified. No arithmetic inconsistencies were detected.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Statistical methods are well described, exact p-values and effect sizes with CIs are reported, and proportional hazards assumptions are tested. Statistical software is not identified, but this is a minor omission.

Evidence

direct quote[Results, paragraph 3]

“Metastasis-free survival was improved in patients allocated to long-course ADT compared with short-course ADT (HR 0·773 [95% CI 0·612–0·975]; p=0·029).”

direct quote[Methods, Statistical analysis]

“The Grambsch–Therneau test was used to test the proportional hazards assumption, with restricted mean survival time becoming the primary estimate of effect if non-proportional hazards were detected.”

absence[Methods, Statistical analysis]

Statistical software is not identified.

PASSReviewer 2· 90% conf

Statistical methods are rigorous and well-described. Tests are named, assumptions are checked (proportional hazards), exact p-values and confidence intervals are reported, and data presentation includes Kaplan-Meier curves with risk tables. The analysis follows a pre-specified plan.

Evidence

direct quote[Methods, Statistical analysis]

“The statistical significance of differences between groups was evaluated with the log-rank test, stratified by randomisation minimisation factors. Effect estimates were obtained from Cox regression models, also stratified by randomisation minimisation factors. The Grambsch–Therneau test was used to test the proportional hazards assumption”

direct quote[Results, paragraph 3]

“Metastasis-free survival was improved in patients allocated to long-course ADT compared with short-course ADT (HR 0·773 [95% CI 0·612–0·975]; p=0·029)”

direct quote[Figure 2 caption]

“Risk tables present the number of participants who, at each timepoint, remain at risk, have been censored, or have had an event.”

PASSReviewer 3· 95% conf

Statistical methods are rigorous and well described: log-rank tests, Cox regression, competing risks, and pre-specified subgroup analyses. Exact p-values and confidence intervals are reported. The proportional hazards assumption was tested. Data presentation includes Kaplan-Meier curves and risk tables.

Evidence

direct quote[Methods, Statistical analysis]

direct quote[Results, paragraph 3]

“Metastasis-free survival was improved in patients allocated to long-course ADT compared with short-course ADT (HR 0·773 [95% CI 0·612–0·975]; p=0·029).”

The data sharing section describes a controlled access mechanism via email and website, with a formal review process. This is adequate for patient-level data. Repository deposit and accession numbers are not applicable for this clinical trial (no sequencing or imaging data). Custom analysis code is not mentioned or shared, which is a minor gap.

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositN/A

data availability statementADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

A concrete data sharing statement is provided with a managed access process, but analysis code is not shared and no repository deposit is made (though this is appropriate for patient-level data).

Evidence

direct quote[Data sharing]

“The RADICALS trial data are held at the MRC Clinical Trials Unit at University College London (UCL), which encourages optimal use of data by using a controlled access approach to data sharing. Requests for data can be made at any time and can be initiated by email to mrcctu. datareleaserequest@ucl.ac.uk or via our website.”

absence[Data sharing]

No code sharing statement is provided.

WARNReviewer 2· 85% conf

A data availability statement is present, describing a controlled access approach via the MRC Clinical Trials Unit. However, the statement is somewhat vague about the specific conditions and timeline for access, and no code sharing is mentioned.

Evidence

direct quote[Data sharing section]

“The RADICALS trial data are held at the MRC Clinical Trials Unit at University College London (UCL), which encourages optimal use of data by using a controlled access approach to data sharing.”

absence[Data sharing section]

No code sharing is mentioned.

PASSReviewer 3· 90% conf

A data availability statement is present, describing a controlled access approach via the MRC Clinical Trials Unit. This is appropriate for a clinical trial with patient-level data. No code sharing is mentioned, but the statistical analysis plan is published.

Evidence

direct quote[Data sharing]

“The RADICALS trial data are held at the MRC Clinical Trials Unit at University College London (UCL), which encourages optimal use of data by using a controlled access approach to data sharing.”

direct quote[References, reference 8]

“Parker CC, Parmar MKB, Sydes MR, Cook A. RADICALS trial statistical analysis plan. 2022 May 27. https://doi.org/10.5281/zenodo.6586525”

Methods are comprehensive. Trial registration numbers are given. All pre-specified outcomes are reported or explained if not presented. A thorough limitations section is included. Conclusions appropriately acknowledge the lack of overall survival benefit and the trade-off with toxicity. Funding sources and conflicts of interest are detailed. The CONSORT checklist is not explicitly referenced, but the paper adheres to its structure.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The manuscript is transparent: methods are detailed, trial registration is provided, all outcomes are reported (with reasons for omission), limitations are discussed, conclusions are proportional, and funding/COI are disclosed. A formal reporting guideline is not referenced, but the paper follows CONSORT structure.

Evidence

direct quote[Methods, Study design and participants]

“This study is registered with the ISRCTN registry, ISRCTN40814031, and with ClinicalTrials.gov (https://clinicaltrials.gov/) , NCT00541047.”

direct quote[Discussion, paragraph 3]

“RADICALS-HD also has several limitations. Based on the recent results from the RADICALS-RT trial , and the ARTISTIC meta-analysis, postoperative radiotherapy is now typically given in the salvage, rather than the adjuvant, setting.”

direct quote[Role of the funding source and Declaration of interests]

“The funders of the study had no role in study design (other than organising initial peer review by independent reviewers), data collection, data analysis, data interpretation, or writing of the report.”

PASSReviewer 2· 95% conf

Reporting is comprehensive and transparent. The trial is registered, methods are detailed, limitations are discussed, conclusions are proportional, and funding and conflicts of interest are disclosed. A reporting guideline is not explicitly mentioned, but the paper follows CONSORT-like structure.

Evidence

direct quote[Methods, Study design and participants]

“This study is registered with the ISRCTN registry, ISRCTN40814031, and with ClinicalTrials.gov (https://clinicaltrials.gov/) , NCT00541047 .”

direct quote[Discussion, paragraph 6]

“RADICALS-HD also has several limitations.”

direct quote[Funding and Declaration of interests sections]

“Grant funding in the UK was provided by the Clinical Trials Advisory Award Committee on behalf of Cancer Research UK (UK/C7829/A6381). Funding in Canada was provided by the Canadian Cancer Society (704970).”

PASSReviewer 3· 95% conf

The trial is registered (ISRCTN40814031, NCT00541047), methods are detailed, limitations are discussed, conclusions are proportional, and funding/COI are disclosed. No specific reporting guideline (e.g., CONSORT) is mentioned, but the paper follows standard clinical trial reporting conventions.

Evidence

direct quote[Methods, Study design and participants]

“This study is registered with the ISRCTN registry, ISRCTN40814031, and with ClinicalTrials.gov (https://clinicaltrials.gov/), NCT00541047.”

direct quote[Discussion, paragraph 5]

“RADICALS-HD also has several limitations. Based on the recent results from the RADICALS-RT trial, and the ARTISTIC meta-analysis, postoperative radiotherapy is now typically given in the salvage, rather than the adjuvant, setting.”

direct quote[Discussion, paragraph 1]

“This metastasis-free survival benefit should be weighed against the extended duration of the well-known adverse effects associated with ADT, such as sexual dysfunction, metabolic syndrome, and osteoporosis.”

3 copyedit issues flagged (1 major): mostly consistency, clarity.

Checked 17 references: 15 verified — 2 not checked.

Reproducibility

4 data/code links checked; 4 live; 1 resolved to content that does not match the paper.

Registered (3 IDs: ClinicalTrials.gov, ISRCTN, PROSPERO). No reporting guideline cited.

Adcurare Rigor Action ItemsFinal pass before journal submission

Ready after minor edits. The paper is methodologically sound. The primary pre-submission actions are to (1) correct the Denmark percentage typo in Table 1 (copyedit, critical), (2) name the ethics committees or provide protocol numbers in the main text, and (3) add a statement about regulatory compliance. These are quick fixes. The paper does not require substantive revision and is suitable for submission after addressing these items.

1.
HIGHcopyedit
Correct the Denmark percentage in Table 1 for the short-course ADT group: change '35 (95%)' to '35 (5%)' or the accurate percentage based on the denominator (35/761 ≈ 4.6%).
This is an impossible percentage (95%) that reviewers will notice immediately and raises questions about data integrity; it must be fixed before submission.
2.
HIGHethics
Add the names of the specific ethics committees or institutional review boards, and/or the relevant protocol approval numbers, to the main text (Methods, Study design and participants).
The current statement referencing the appendix is inadequate for direct verification; ethics committees must be identifiable in the manuscript.
3.
HIGHreporting
State explicitly that the trial was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines, or add a regulatory compliance statement.
This is standard for human trials and is currently missing, which leaves a reporting gap that a journal editor may flag.
4.
HIGHreporting
Name the statistical software package (e.g., Stata, SAS, R) and version used for all analyses in the Methods, Statistical analysis section.
Reproducibility requires knowing the software environment; this is a minor but universally expected reporting element.
5.
HIGHdata code
Add a statement about the availability of analysis code, even if only upon request, to the Data sharing section.
Code is a key part of reproducibility; its absence is a gap in the data/code availability dimension.
6.
HIGHreporting
Provide the manufacturers (company, city, country) for the androgen deprivation therapy drugs used (GnRH analogue, bicalutamide, degarelix) in the Methods, Procedures section.
Key resources should identify suppliers for all investigational products to enable replication.
7.
MEDIUMreporting
Reference the CONSORT reporting checklist in the Methods section, or state that the paper follows CONSORT guidelines.
Though the paper follows CONSORT structure, explicitly citing the guideline improves transparency.
8.
MEDIUMcopyedit
Clarify the original power calculation sentence in Methods, Statistical analysis: 'This separated, pairwise comparison required approximately 1077 patients to observe 91 events' should be contextualised as the original design before the endpoint change.
The sentence could be misinterpreted as the final sample size; providing context improves clarity.
9.
MEDIUMreporting
Add weight/BMI to the baseline characteristics table (Table 1) or explain why these data are not reported.
Weight and health status are expected biological variables in a human trial; their absence is a minor reporting gap.
10.
LOWreporting
Report the number of patients who received each type of ADT (GnRH agonist vs bicalutamide vs degarelix) in the results for completeness.
Describing actual treatment received enhances the understanding of intervention adherence and subgroup analysis context.

Full text (54,205 chars)Analyzed: Jul 7, 2026

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Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial.

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DOI

10.1016/S0140-6736(24)00549-X

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