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A Randomized Open-label Phase 2 Study of TALazoparib With or Without ENzaluTamide in Patients With Metastatic Castration-Resistant Prostate Cancer and HRR Mutations After Progression on Abiraterone Acetate (TALENT)
The purpose of this study is to find out whether talazoparib in combination with enzalutamide or talazoparib alone delays cancer progression in people with metastatic castration-resistant prostate cancer (mCRPC) who have homologous recombination repair (HRR) mutations and have previously received abiraterone acetate.
Details
| Lead sponsor | Prostate Cancer Clinical Trials Consortium |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 126 |
| Start date | 2026-05 |
| Completion | 2030-03 |
Conditions
- Prostate Cancer (Adenocarcinoma)
- mCRPC (Metastatic Castration-resistant Prostate Cancer)
Interventions
- Talazoparib with enzalutamide
- Talazoparib
Primary outcomes
- radiographic progression free survival (rPFS) — From treatment initiation until documented disease progression, death, lost to follow-up, withdrawal, administrative censoring at the time of final analysis, assessed at approximately 42 months from the start of enrollment.
To compare the efficacy of talazoparib + enzalutamide to talazoparib alone as measured by rPFS as assessed by the Investigator.
Countries
United States