Study on olaparib plus abiraterone as first-line therapy in men with metastatic castration-resistant prostate cancer
Study on olaparib plus abiraterone as first-line therapy in men with metastatic castration-resistant prostate cancer
ClinicalTrials.gov ID: NCT03732820
Sponsor: AstraZeneca
Information provided by: AstraZeneca (Responsible Party)
Last Update Posted: 2024-07-30
Brief Summary:
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.
Detailed Description:
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) (first-line setting).
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.
Official Title:
A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PROpel Study)
Intervention / Treatment:
- Drug: olaparib
- Drug: abiraterone acetate
| Category | Value |
|---|---|
| Study Start (Actual) |
2018-10-31
|
| Primary Completion (Actual) |
2021-07-30
|
| Study Completion (Estimated) |
2024-11-04
|
| Enrollment (Actual) | 895 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
D081SC00001
2018-002011-10 (EudraCT Number) |