Study of Talazoparib and Enzalutamide in Men with Specific Gene Mutations in Metastatic Prostate Cancer
Sponsor: Pfizer
ClinicalTrials ID:NCT04821622
This study is testing the safety and effectiveness of combining the drug talazoparib with enzalutamide, compared to a placebo with enzalutamide, in men with metastatic prostate cancer that has specific gene mutations.
Patient Parameters
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Program Overview
The study aims to find out if the combination of talazoparib and enzalutamide is safe and effective for treating men with metastatic prostate cancer that has certain gene mutations. Participants will be randomly assigned to receive either the combination of talazoparib and enzalutamide or a placebo with enzalutamide. The study will include several phases: prescreening, screening, treatment, safety follow-up, and long-term follow-up.
Description
The study will involve about 550 men with metastatic prostate cancer. Participants will be randomly divided into two groups: one group will receive talazoparib with enzalutamide, and the other group will receive a placebo with enzalutamide. The treatment with talazoparib or placebo will be blinded, meaning neither the participants nor the researchers will know who is receiving which treatment. Enzalutamide will be given openly at a dose of 160 mg per day. Talazoparib or placebo will be given at a dose of 0.5 mg once daily, but for those with moderate kidney issues, the dose will be 0.35 mg once daily. The study will monitor the safety and effectiveness of these treatments over time.
Eligibility Criteria
Inclusion Criteria
- Men aged 18 or older (20 in Japan, 19 in Korea) with confirmed prostate cancer.
- Must have a specific gene mutation related to DNA damage repair (DDR).
- Must be willing to provide tumor tissue for analysis.
- Must be undergoing androgen deprivation therapy (ADT) if not surgically castrated.
- Must have metastatic prostate cancer confirmed by scans.
- Must not have received prior treatment with docetaxel for metastatic prostate cancer.
- Must have good overall health and organ function.
- Must agree to use contraception during and after the study.
- Must be able to comply with study procedures and provide informed consent.
Exclusion Criteria
- Have other serious medical or psychiatric conditions that could interfere with the study.
- Have a history of seizures or conditions that may lead to seizures.
- Have had major surgery within 4 weeks before starting the study.
- Have known brain metastasis or spinal cord issues.
- Have had other cancers, except for certain skin cancers or cancers treated over 3 years ago.
- Have significant heart or blood pressure issues.
- Have active COVID-19 infection.
- Have received certain treatments for prostate cancer recently.
- Have allergies to study drugs or their components.
- Are currently using certain medications that could interfere with the study.
- Are involved in another clinical trial or have received investigational treatments recently.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham | 35233 | Birmingham | Alabama |
| University of Alabama at Birmingham | 35249 | Birmingham | Alabama |
| Arizona Institute of Urology, PLLC | 85704 | Tucson | Arizona |
| Beverly Hills Cancer Center | 90211 | Beverly Hills | California |
| Adventist Health Glendale | 91206 | Glendale | California |
| VA Long Beach Healthcare System | 90822 | Long Beach | California |
| Yale-New Haven Hospital | 06510 | New Haven | Connecticut |
| MedStar Georgetown University Hospital | 20007 | Washington D.C. | District of Columbia |
| Washington Cancer Institute at MedStar Washington Hospital Center | 20010 | Washington D.C. | District of Columbia |
| AdventHealth Medical Group Hematology and Oncology | 32804 | Orlando | Florida |
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