The purpose of this study is to evaluate the efficacy and safety (including evaluating side
effects) of combination of olaparib and abiraterone versus placebo and abiraterone in
patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no
prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant
prostate cancer (mCRPC) stage.
PROpel is a phase III study evaluating the efficacy, safety, and tolerability of olaparib
versus placebo when given in addition to abiraterone to patients with metastatic
castration-resistant prostate cancer (mCRPC) who have not received prior chemotherapy or new
hormonal agents (NHAs) for metastatic castration-resistant prostate cancer (mCRPC)
Approximately 720 patients globally were planned to be randomized in PROpel in a 1:1 ratio to
treatment with either olaparib and abiraterone or placebo and abiraterone. Enrolment had
completed with a total of 796 patients randomised. Following the completion of global
enrolment, the China cohort will randomise approximately 108 additional patients at sites in
China, also in a 1:1 ratio.
Patients will receive oral treatment with olaparib 300 mg twice daily + abiraterone 1000 mg
once daily or placebo twice daily + abiraterone 1000 mg once daily. Patients in both
treatment groups will also receive either prednisone or prednisolone 5 mg twice daily.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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