TALAPRO-3 PATIENT SUMMARY
This trial is for people with metastatic castration-sensitive prostate cancer (mCSPC) and DNA damage repair (DDR) gene alteration.
TALAPRO-3 is a phase 3 clinical trial beginning in 2021. This trial will enroll about 550 participants from 29 different countries.
The purpose of TALAPRO-3 is to learn if talazoparib (the study medicine) is safe, and if the combination of talazoparib plus enzalutamide (an approved treatment for prostate cancer) is more effective than enzalutamide alone.
The TALAPRO-3 clinical trial is enrolling men over 18 who have been diagnosed with metastatic castration-sensitive prostate cancer (mCSPC), which means that the tumor has spread to other parts of the body but is still sensitive to hormone therapies.
Participants in this study will be randomly assigned to 2 treatment groups. Half of participants will receive enzalutamide and talazoparib (the study drug), and the other half will receive enzalutamide and a placebo (tablet with no active ingredient). All participants in this study will need to take about 6 capsules by mouth once a day and attend at least 25 clinic visits over about 3 years.
Possible benefits for participants include slowing down or stopping the progression of their prostate cancer and potentially prolonging their life. Participants will also be monitored under close medical supervision for safety during the study period.
Possible participant risks: The use of talazoparib (the study drug) with enzalutamide may not provide any benefit for slowing down or stopping the progression of the participants’ prostate cancer. The use of talazoparib (the study drug) with enzalutamide may also cause side effects.
If you are interested in this trial, you can find additional information and see if you are eligible to participate at the links below:
Clinical Trial Sites: Trials can be found here.
If you are interested in this trial, review the following:
Register your interest or comments about this trial with PHEN
PHEN Contact: 617-481-4020
Please Note: This information is provided for educational and awareness purposes. A decision on clinical trials participation is to be made between the patient and his doctor.