The Absolute Effect / Oncology Evidence / Evidence Index

Prostate Cancer · Medical · Advanced / Metastatic · First-line mCRPC · HRR-deficient and all-comer cohorts

TALAPRO-2

In metastatic castration-resistant prostate cancer, does talazoparib plus enzalutamide improve survival over enzalutamide alone, and how does benefit vary by HRR status?

Registry: NCT03395197 · Evidence reviewed 9 November 2026 · Aliases and follow-up publications consolidated.

Phase III double-blind placebo-controlled; all-comer cohort n=805.Primary-source evidence summary

Study design, population and eligibility

Design and sample

Phase III double-blind placebo-controlled; all-comer cohort n=805.

Population

mCRPC progressing on ADT; chemotherapy-naive in mCRPC setting.

Treatment and comparator

Intervention: Talazoparib + enzalutamide + ADT.

Comparator: Placebo + enzalutamide + ADT.

Endpoints

rPFS primary; OS key secondary.

Key efficacy and clinical outcomes

Final all-comer OS 45.8 vs 37.0 mo (HR 0.80); HRR-deficient cohort 45.1 vs 31.1 mo (HR 0.62).

Source-reported outcome visualization

Values are reproduced from the cited report; bars are scaled within this figure. First-line mCRPC · HRR-deficient and all-comer cohorts

Median OS talazoparib+enzalutamide
45.8%
Median OS enzalutamide
37%

Median survival and hazard ratios are not fixed-time event risks; NNT is not inferred from them.

Toxicity and treatment burden

Grade ≥3 anaemia 49% vs 4%, neutropenia 19% vs 1% in all-comer cohort.

Absolute effect and NNT/NNH

Benefit greatest in HRR-deficient/BRCA-altered disease; genomic testing and marrow reserve matter.

NNT/NNH is not calculated unless a directly reported, comparable fixed-time risk difference supports it. Median survival and hazard ratios alone do not provide an NNT.

Critical interpretation and limitations

Benefit greatest in HRR-deficient/BRCA-altered disease; genomic testing and marrow reserve matter.

This page is an evidence summary, not a substitute for multidisciplinary assessment or patient-specific decision-making.

Current-practice context

Review date: 9 November 2026. Primary publication and selected follow-up sources were reviewed. Full disease-specific guideline, regulatory-label and sequencing audit remains pending; verify current local recommendations and biomarker eligibility before clinical application.

Primary publication and authoritative source

https://pubmed.ncbi.nlm.nih.gov/40683290/

ClinicalTrials.gov NCT03395197