Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men with Metastatic Castration-Resistant Prostate Cancer (PROfound Study)
Study identifier:D081DC00007
ClinicalTrials.gov identifier:NCT02987543
EudraCT identifier:2016-000300-28
CTIS identifier:N/A
Study Complete
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)
Medical condition
metastatic castration-resistant prostate cancer
Phase
Phase 3
Healthy volunteers
No
Study drug
olaparib, enzalutamide, abiraterone acetate
Sex
Male
Actual Enrollment
387
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 06 Feb 2017
Primary Completion Date: 04 Jun 2019
Study Completion Date: 15 Feb 2023
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Sept 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Foundation Medicine, Inc., Myriad Genetics, Inc.
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Olaparib Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose of 300 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions | Drug: olaparib 300 mg (2x 150 mg tablets) twice daily Other Name: Lynparza |
| Active Comparator: Enzalutamide OR abiraterone acetate Enzalutamide: Enzalutamide is available as capsules or tablets containing 40 mg of enzalutamide. Subjects will be administered study treatment orally at a dose of 160 mg once daily. Abiraterone acetate with prednisone: Abiraterone acetate is available as tablets containing 250 mg or 500 mg of abiraterone acetate. Subjects will be administered study treatment orally at a dose of 1,000 mg once daily in combination with prednisone 5 mg administered twice daily orally. Prednisolone is permitted for use instead of prednisone if necessary. | Drug: enzalutamide 160 mg (4 x 40 mg capsules) once daily Other Name: XTANDI Drug: abiraterone acetate 1,000 mg (4 x 250 mg tablets) once daily Other Name: ZYTIGA Drug: abiraterone acetate 1,000 mg (2 x 500 mg tablets) once daily Other Name: ZYTIGA Drug: enzalutamide 160 mg (4 x 40 mg tablets) once daily Other Name: XTANDI |
Contacts
Investigators
Principal Investigator
Johann de Bono
The Institute of Cancer Research, United Kingdom
