Talazoparib ± Enzalutamide for Prostate Cancer
(TALENT Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires stopping certain medications before participation. You must not use potent P-gp inhibitors, strong CYP2C8 inhibitors, strong CYP3A4 inducers, or certain hormonal agents within specified periods before starting the study. Check with the trial team to see if your current medications are on the list.
What data supports the effectiveness of the drug combination Talazoparib and Enzalutamide for prostate cancer?
Research shows that Talazoparib, when used with Enzalutamide, has potential benefits for men with metastatic castration-resistant prostate cancer, especially those with specific genetic changes related to DNA repair. This combination has shown promise in improving the time patients live without their cancer getting worse.12345
Is Talazoparib plus Enzalutamide safe for humans?
How is the drug Talazoparib different from other prostate cancer treatments?
Research Team
Alicia Morgans, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Men over 18 with advanced prostate cancer that's resistant to castration and has specific genetic mutations. They must have had prior treatment with abiraterone, be able to swallow pills, have good performance status (ECOG ≤1), normal organ function, and agree to contraception. Excluded are those with allergies to the drugs tested, other active cancers needing treatment within 3 years, seizure history or risks, certain medical conditions or treatments that could interfere.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive talazoparib with or without enzalutamide in continuous 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Enzalutamide
- Talazoparib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Prostate Cancer Clinical Trials Consortium
Lead Sponsor
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Dana-Farber Cancer Institute
Collaborator
Memorial Sloan Kettering Cancer Center
Collaborator