This trial is for patients with metastatic Castration-Resistant Prostate Cancer who have not received prior treatment for Castrate-Resistant disease.

Trial Description

The purpose of the TALAPRO-2 clinical trial is to evaluate the length of time between starting treatment and any further disease progression in men with metastatic (spreading) castration-resistant prostate cancer. Patients are separated into two arms of this study. The first is treated with the PARP-inhibitor talazoparib plus enzalutamide and the second receive enzalutamide (Xtandi) alone.

Patients enrolled in this study will either receive talazoparib 0.5 mg daily plus enzalutamide 160 mg daily or enzalutamide 160 mg daily. Talazoparib and enzalutamide are both taken by mouth, once a day. Talazoparib has been previously FDA approved for use in breast cancer. Enzalutamide has been FDA approved for use in prostate cancer.

TALAPRO-2 is a phase 3 clinical trial that will enroll 872 participants. The trial began in 2017 and the primary completion date is in 2022.

Possible patient benefits include slowing down or stopping the progression of prostate cancer and potentially prolonging life. Patients will also be monitored under close medical supervision for safety during the study period.

Possible patient risks:  The use of talazoparib with enzalutamide will provide no benefit for preventing disease progression in these patients. The use of talazoparib with enzalutamide may also cause side-effects.

Organization: Pfizer

If you are interested in this trial you can take these actions:

More information and to check your eligibility for this trial:

• Visit www.clinicaltrials.gov

• Trial Sites and Locations

• Use the “clinical trials glossary” and “dictionary” for words, phrases and treatments that you may not understand. 

• Register your interest or comments about this trial with PHEN