Trials / Completed
CompletedNCT02987543
Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 387 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- Male
- Age
- 18 Years – 130 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a prospective, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of olaparib versus enzalutamide or abiraterone in subjects with metastatic castration-resistant prostate cancer (mCRPC) who have failed prior treatment with a new hormonal agent (NHA) and have a qualifying tumor mutation in one of 15 genes involved in the homologous recombination repair (HRR) pathway. Subjects will be divided into two cohorts based on HRR gene mutation status. Approximately 340 subjects will be randomized 2:1 (olaparib : investigator choice of enzalutamide or abiraterone acetate) into the trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | olaparib | 300 mg (2x 150 mg tablets) twice daily |
| DRUG | enzalutamide | 160 mg (4 x 40 mg capsules) once daily |
| DRUG | abiraterone acetate | 1,000 mg (4 x 250 mg tablets) once daily |
| DRUG | abiraterone acetate | 1,000 mg (2 x 500 mg tablets) once daily |
| DRUG | enzalutamide | 160 mg (4 x 40 mg tablets) once daily |
Timeline
- Start date
- 2017-02-06
- Primary completion
- 2019-06-04
- Completion
- 2023-02-15
- First posted
- 2016-12-09
- Last updated
- 2023-10-06
- Results posted
- 2020-10-12
Locations
204 sites across 20 countries: United States, Argentina, Australia, Austria, Brazil, Canada, Denmark, France, Germany, Israel, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02987543. Inclusion in this directory is not an endorsement.