OncRef

Clinical Trial: NCT02987543

Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:AstraZeneca
Information Provided By:AstraZeneca
Last Update Posted:2023-10-06

Study Overview

Brief 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.

Official Title

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)

Conditions

Metastatic Castration-resistant Prostate Cancer

Intervention / Treatment

  • Drug: olaparib
  • Drug: enzalutamide
  • Drug: abiraterone acetate
  • Drug: abiraterone acetate
  • Drug: enzalutamide

Other Study ID Numbers

  • D081DC00007
  • 2016-000300-28
  • 2016

Start Date (Actual)

2017-02-06

Primary Completion Date (Actual)

2019-06-04

Study Completion Date (Actual)

2023-02-15

Enrollment (Actual)

387

Study Type

Interventional

Phase

Phase 3