CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 387 enrolled
Drug / intervention
olaparib +4 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/NCT02987543
NCT02987543Phase 3Completed
CompareCT.gov

A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have Homologous Recombination Repair Gene Mutations (PROfound)

AstraZeneca·interventional·Posted Dec 9, 2016·Updated Oct 6, 2023

In Brief

A Phase 3 clinical trial evaluating olaparib, enzalutamide, and 1 other intervention for Metastatic Castration-resistant Prostate Cancer. Completed, enrolled 387 participants across 204 sites in 20 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Castration-resistant Prostate Cancer
CountriesArgentina, Australia, Austria, Brazil, Canada, Denmark, France, Germany, Israel, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
CollaboratorsMerck Sharp & Dohme LLC, Foundation Medicine, Myriad Genetics, Inc.

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 9, 2016
Enrollment StartFeb 6, 2017
Primary CompletionJun 4, 2019
Study CompletionFeb 15, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.6 years ago

Interventions

olaparibdrug

300 mg (2x 150 mg tablets) twice daily

enzalutamidedrug

160 mg (4 x 40 mg capsules) once daily

abiraterone acetatedrug

1,000 mg (4 x 250 mg tablets) once daily

abiraterone acetatedrug

1,000 mg (2 x 500 mg tablets) once daily

enzalutamidedrug

160 mg (4 x 40 mg tablets) once daily