A Study Using the Research Drug Talazoparib with Enzalutamide to Treat Your Prostate Cancer
Technical Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Talazoparib with Enzalutamide in Metastatic Castration-Resistant Prostate Cancer
Disease Type: Metastatic, castration-resistant prostate cancer (mCRPC)
Basic information: The purpose of this study is to see if the addition of the study drug, talazoparib, to enzalutamide, provides additional benefit when compared to enzalutamide with placebo. Talazoparib is a pill that is taken by mouth. It is thought to work by stopping the activity of certain proteins, called PARP1 and PARP2, that are found in normal and cancerous cells and that are involved in DNA repair. Enzalutamide is a routine, FDA-approved treatment for men with mCRPC.
If you participate in the study, you will be randomized (assigned by chance) to receive either talazoparib or placebo. This is a double-blinded study, which means that neither you nor your doctor nor the study team will know whether you receive talazoparib or placebo. No matter which group you are assigned to, you will still be treated with enzalutamide.
In order to participate in this study, you must agree to have a sample of your tumor tissue tested for defects in a set of genes being investigated in the study, unless you already have results from the same testing company.
The study will enroll two cohorts of patients. Cohort 1, the first group, will enroll patients regardless of the results of the tissue test described above. Cohort 2, the second group, will only enroll patients who have a specific genetic defect called DNA Damage Repair deficiencies.
Research Procedures (not a complete list): Once you begin treatment, you will need to come to clinic every 2 weeks for approximately the first 4 months, then every 4 weeks through approximately the first year, and then approximately every 8 weeks until study treatment is stopped. You will also need to return for scans approximately every 8 weeks.
Eligibility Criteria (Not a complete list):
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