NCT06844383 A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate
| NCT ID | NCT06844383 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Prostate Cancer Clinical Trials Consortium |
| Condition | Prostate Cancer (Adenocarcinoma) |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2026-05 |
| Primary Completion | 2029-03 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria • Willing and able to provide, or have a legally authorized representative provide, written informed consent and privacy authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed. NOTE: Privacy authorization may be either included in the informed consent or obtained separately. * Participants ≥ 18 years of age. * Are willing to be randomized into either study arm and adhere to the study protocol. * Ability to swallow study capsules and/or tablets whole. * Are willing to remain on study treatment and to continue undergoing study imaging despite PSA progression unless clinically deteriorating. * Histological or cytological proof of adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features. * Presence of a pathogenic homologous recombination repair mutation in at least one of the following genes on tumor tissue or circulating tumor DNA testing: BRC
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