Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC
Summary
The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC.
Timeline
- Start
- 2021-05-12
- Primary completion
- 2026-02-18
- Completion
- 2027-08-28
Outcome
Met primary endpoint
paper Talazoparib added to enzalutamide led to significantly better imaging-based progression-free survival than placebo plus enzalutamide among patients with metastatic APMS prostate cancer harboring alterations in homologous recombination repair genes. PMID 42223064 ↗
release “Primary endpoint met in Phase 3 TALAPRO-3 study demonstrating a statistically significant and clinically meaningful reduction in risk of disease progression or death” pfizer.com ↗
release “First PARP inhibitor + ARPI combination to show consistent rPFS improvement in HRR gene‑altered metastatic hormone‑sensitive prostate cancer, including both BRCA and non‑BRCA alterations” pfizer.com ↗
release “TALZENNA plus XTANDI demonstrated a 52% reduction in the risk of radiographic progression or death compared to placebo plus XTANDI” pfizer.com ↗
Publications
- Agarwal N, Matsubara N, Azad AA, Saad F, Mateo J, Jiang S, Ye D, Voog E, Shore ND, Cil T, Vulsteke C, Chung HJ, Zschabitz S, Laird AD, Zhang X, Nandoskar P, Chetcuti SF, Wang F, Fizazi K. PARP and Androgen-Signaling Inhibition plus ADT in Metastatic Prostate Cancer. N Engl J Med. 2026 Jul 30;395(5):427-439. doi: 10.1056/NEJMoa2604126. Epub 2026 May 30.
- Agarwal N, Saad F, Azad AA, Mateo J, Matsubara N, Shore ND, Chakrabarti J, Chen HC, Lanzalone S, Niyazov A, Fizazi K. TALAPRO-3 clinical trial protocol: phase III study of talazoparib plus enzalutamide in metastatic castration-sensitive prostate cancer. Future Oncol. 2024 Mar;20(9):493-505. doi: 10.2217/fon-2023-0526. Epub 2023 Oct 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Talazoparib | Small molecule | 0.35 mg | — |
| Subject | Talazoparib | Small molecule | 0.5 mg | — |
| Background | Enzalutamide | Other / unclassified | 160 mg | — |