CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 895 enrolled / 895 target
Drug / intervention
olaparib +1 moredrug
Likely dose
olaparib 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03732820
NCT03732820Phase 3ActiveUpdate Overdue (9.7/mo)Completion was 59mo ago
CompareCT.gov

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)

AstraZeneca·interventional·Posted Nov 7, 2018·Updated Jun 2, 2026

In Brief

A Phase 3 clinical trial evaluating olaparib and abiraterone acetate for Metastatic Castration-resistant Prostate Cancer. Active but no longer recruiting, targeting 895 participants across 132 sites in 17 countries.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Castration-resistant Prostate Cancer
CountriesAustralia, Belgium, Brazil, Canada, Chile, Czechia, France, Germany, Italy, Japan, Netherlands, Slovakia, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 3Active
201920202021202220232024202520262027
First PostedNov 7, 2018
Enrollment StartOct 31, 2018
Primary CompletionJul 30, 2021
Study CompletionFeb 5, 2027
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 7.7 years ago

Arms & Interventions

olaparib plus abirateroneexperimental

Olaparib is available as a film-coated tablet containing 100 milligrams (mg) or 150 milligrams (mg) of olaparib. Subjects will be administered olaparib orally at a dose of 300 milligrams (mg) twice daily (bid). The initial dosage of 300 milligrams (mg) twice daily will be composed of 2 x 150 milligrams (mg) tablets per dose. The 100 milligrams (mg) and 150 milligrams (mg) tablets will be used to manage dose reductions during the study. Abiraterone acetate with prednisone or prednisolone will be sourced locally as commercially available materials. Subjects will be administered abiraterone orally at a dose of 1000 milligrams (mg) once daily, in combination with prednisone or prednisolone 5 milligrams (mg) administered orally twice daily.

Drug: olaparibDrug: abiraterone acetate
placebo plus abirateroneplacebo_comparator

Placebo to match olaparib is available as a film-coated tablet in 100 milligrams (mg) or 150 milligrams (mg). Subjects will be administered placebo orally at a dose of 300 milligrams (mg) twice daily (bid). The initial dosage of 300 milligrams (mg) twice daily will be composed of 2 x 150 milligrams (mg) tablets per dose. The 100 milligrams (mg) and 150 milligrams (mg) tablets will be used to manage dose reductions during the study. Abiraterone acetate with prednisone or prednisolone will be sourced locally as commercially available materials. Subjects will be administered abiraterone orally at a dose of 1000 milligrams (mg) once daily, in combination with prednisone or prednisolone 5 milligrams (mg) administered orally twice daily.

Drug: abiraterone acetate

Interventions

olaparibdrug

300 mg (2 x 150 milligrams (mg) tablets) twice daily

abiraterone acetatedrug

1000 milligrams (mg) once daily