RecruitingPhase 2NCT06844383

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

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


Sponsor

Prostate Cancer Clinical Trials Consortium

Enrollment

126 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment approaches for men with prostate cancer that has stopped responding to a hormone-blocking therapy called abiraterone acetate: one group receives a PARP inhibitor called talazoparib plus enzalutamide (a hormone therapy), and the other receives talazoparib alone. **You may be eligible if...** - You are 18 or older with a diagnosis of prostate cancer - Your cancer previously received treatment with abiraterone acetate - Your cancer has progressed (worsened) despite that treatment **You may NOT be eligible if...** - You have had certain prior cancer therapies that conflict with the study drugs - You have significant heart problems or uncontrolled other medical conditions - You have bone fracture risks that are unmanaged - Your cancer has spread to the brain Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTalazoparib with enzalutamide

Talazoparib (0.5 mg PO QD) and enzalutamide (160 mg PO QD) will be administered in continuous 28-day cycles.

DRUGTalazoparib

Talazoparib (1 mg PO QD) will be administered in continuous 28-day cycles.


Locations(2)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

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NCT06844383


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