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Recruiting Phase 2 NCT06844383

NCT06844383 A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate

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Clinical Trial Summary
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

Condition Prostate Cancer (Adenocarcinoma)
Sponsor Prostate Cancer Clinical Trials Consortium
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 126
Sex MALE
Min Age 18 Years
Max Age N/A
Start Date 2026-05
Completion 2029-03
Interventions
Talazoparib with enzalutamideTalazoparib

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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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