Talazoparib + Enzalutamide for Metastatic Prostate Cancer
Trial Summary
What is the purpose of this trial?
The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, ongoing ADT (androgen deprivation therapy) with a GnRH agonist or antagonist must continue throughout the study. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of the drug combination Talazoparib and Enzalutamide for metastatic prostate cancer?
Research shows that Talazoparib, when combined with Enzalutamide, has potential benefits for treating metastatic prostate cancer, especially in patients with specific genetic changes. Enzalutamide alone has already been proven to improve survival in men with metastatic hormone-sensitive prostate cancer.12345
Is the combination of Talazoparib and Enzalutamide safe for humans?
What makes the drug combination of talazoparib and enzalutamide unique for treating metastatic prostate cancer?
The combination of talazoparib and enzalutamide is unique because it pairs a PARP inhibitor (talazoparib) with an androgen receptor-targeted therapy (enzalutamide), which may improve treatment effectiveness for metastatic prostate cancer, especially in patients with specific genetic alterations related to DNA repair.12346
Research Team
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Eligibility Criteria
Men 18+ (varies by country) with metastatic prostate cancer and confirmed DDR gene mutation. They must have adequate organ function, no prior docetaxel treatment for mCSPC, and agree to contraception use. Exclusions include previous treatments with certain drugs, active COVID-19 infection, history of seizures or major surgery within the last month.Inclusion Criteria
Exclusion Criteria
Timeline
Prescreening
Initial assessment to determine potential eligibility for the trial
Screening
Participants are screened for eligibility to participate in the trial
Double-blind Treatment
Participants receive either talazoparib with enzalutamide or placebo with enzalutamide
Safety Follow-up
Participants are monitored for safety after treatment
Long-term Follow-up
Participants are monitored for long-term outcomes and survival
Treatment Details
Interventions
- Enzalutamide
- Talazoparib
Enzalutamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead 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
Astellas Pharma Inc
Industry Sponsor
Tadaaki Taniguchi
Astellas Pharma Inc
Chief Medical Officer since 2023
MD, PhD
Naoki Okamura
Astellas Pharma Inc
Chief Executive Officer since 2023
University of Tokyo, Faculty of Pharmacy