Evidence map›Paper›PMID 42502892›Full record

Trial reportInternational journal of urology : official journal of the Japanese Urological Association2026

Exploratory Time-Dependent Patterns in Estimated Treatment Effect of Talazoparib Plus Enzalutamide in HRR Non-Deficient or Unknown Metastatic Castration-Resistant Prostate Cancer: A Post Hoc Analysis of the TALAPRO-2 Trial.

Shugo Yajima, Soichiro Yoshida, Wei Chen, Hiroshi Fukushima, Hajime Tanaka, Hiroyuki Sato, Akihiro Hirakawa, Hitoshi Masuda, Yasuhisa Fujii

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of urology : official journal of the Japanese Urological Association, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03395197 (A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03395197 phase3active not recruitingnot on this map

A phase 3, randomized, double-blind, placebo-controlled study of talazoparib with enzalutamide in metastatic castration-resistant prostate cancer

TypeinterventionalSponsorPfizerRan2017 to 2027Enrolled1,054ConditionsmCRPCArmsTalazoparib with enzalutamide, Placebo with enzalutamide
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Shugo YajimaDepartment of Urology, National Cancer Center Hospital East, Chiba, Japan.
Soichiro YoshidaDepartment of Urology, Institute of Science Tokyo, Tokyo, Japan.ORCID https://orcid.org/0000-0003-2757-8083
Wei ChenDepartment of Urology, Institute of Science Tokyo, Tokyo, Japan.
Hiroshi FukushimaDepartment of Urology, Institute of Science Tokyo, Tokyo, Japan.
Hajime TanakaDepartment of Urology, Institute of Science Tokyo, Tokyo, Japan.ORCID https://orcid.org/0000-0003-3632-2901
Hiroyuki SatoDepartment of Clinical Biostatistics, Graduate School of Medical and Dental Sciences, Institute of Science Tokyo, Tokyo, Japan.ORCID https://orcid.org/0000-0002-9507-9887
Akihiro HirakawaDepartment of Clinical Biostatistics, Graduate School of Medical and Dental Sciences, Institute of Science Tokyo, Tokyo, Japan.ORCID https://orcid.org/0000-0003-2580-7460
Hitoshi MasudaDepartment of Urology, National Cancer Center Hospital East, Chiba, Japan.
Yasuhisa FujiiDepartment of Urology, Institute of Science Tokyo, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTalazoparib plus enzalutamide improved overall survival (OS) in the biomarker-unselected TALAPRO-2 population, but OS benefit was not statistically significant in the homologous recombination repair (HRR) non-deficient or unknown subgroup, whereas radiographic progression-free survival (rPFS) was prolonged. We explored time-dependent patterns in estimated treatment effects in this subgroup.

methodsApproximate individual-level data for 636 patients were reconstructed from published Kaplan-Meier curves; original trial-level patient data were unavailable. The proportional hazards assumption was assessed using Schoenfeld residuals and log-log plots. Interval-specific hazard ratios (HRs) were estimated using piecewise Cox models. A treatment-by-log(time + 1) interaction was evaluated formally. Sensitivity analyses included alternative interval schemes, landmark analyses, restricted mean survival time (RMST), and descriptive application of the same piecewise framework to the HRR-deficient subgroup.

resultsThe proportional hazards assumption was not rejected for OS (p = 0.63) or rPFS (p = 0.37). For OS, the 36-48-month interval showed a nominally lower hazard with talazoparib (HR 0.59; 95% confidence interval [CI] 0.36-0.97; nominal p = 0.039). For rPFS, the lowest HR occurred at 0-6 months (HR 0.56; 95% CI 0.37-0.86; p = 0.008). Treatment-by-log(time + 1) interactions were not statistically significant for OS (p = 0.44) or rPFS (p = 0.12).

conclusionsThis reconstructed-data post hoc analysis suggested exploratory time-dependent patterns in effect estimates without formal evidence of a time-varying treatment effect. Findings are descriptive, hypothesis-generating, and should not be extrapolated to molecularly confirmed HRR-proficient disease.

trial registrationClinicalTrials.gov: NCT03395197.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsPhenylthiohydantoinPhthalazinesProstatic Neoplasms, Castration-ResistantAgedBenzamidesHumansKaplan-Meier EstimateMaleNitrilesProgression-Free SurvivalProportional Hazards ModelsTime FactorsTreatment OutcomeBenzamidesenzalutamideNitrilesPhenylthiohydantoinPhthalazinestalazoparibmetastatic castration‐resistant prostate cancerpoly(ADP‐ribose) polymerase inhibitorstalazoparib

Identifiers

PMID42502892
PMCPMC13401740

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.