HCC 19-054: TALAPRO-2 Study – Advanced Prostate Cancer

STUDY BASICS

Have you been diagnosed with metastatic castration-resistant prostate cancer? If so, you may be eligible for a research study to help find out if adding an investigational drug called talazoparib to an existing, FDA-approved prostate cancer drug called enzalutamide is a safe and effective treatment.

STUDY PURPOSE

Men who are diagnosed with prostate cancer are often treated with hormone therapy or surgery in an effort to slow the growth of the cancer and shrink the tumor, but the cancer usually begins to grow again within a few years. When these treatments no longer keep the cancer from growing and spreading to other parts of the body, the cancer is called metastatic castrate-resistant prostate cancer (CRPC).

The purpose of this study is to help researchers find out if adding an investigational drug called talazoparib to an existing, FDA-approved prostate cancer drug called enzalutamide is a safe and effective treatment for men with metastatic castrate-resistant prostate cancer. Talazoparib is FDA-approved for use in breast cancer, but is considered investigational for this study.

COULD THIS STUDY BE RIGHT FOR YOU?

• Men aged 18 and up
• Diagnosed with metastatic castration-resistant prostate cancer

WHAT PARTICIPANTS CAN EXPECT

Participation includes an initial screening period to find out if you are eligible. Eligible participants will be randomly assigned (like the flip of a coin) to receive either talazoparib plus enzalutamide or placebo plus enzalutamide.

Clinic visits will be every 2 weeks for approximately the first 4 months (through week 17), then every 4 weeks through week 53, and then approximately every 8 weeks until study treatment is stopped.

Tests and assessments during the study include completing questionnaires, having physical exams, and providing blood and saliva samples.