Study identifier:D081SC00001
ClinicalTrials.gov identifier:NCT03732820
EudraCT identifier:2018-002011-10
CTIS identifier:2024-511144-86-00
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)
metastatic castration-resistant prostate cancer
Phase 3
No
olaparib, abiraterone acetate
Male
895
Interventional
18 Years - 99 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jun 2024 by AstraZeneca
AstraZeneca
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: olaparib plus abiraterone 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: olaparib 300 mg (2 x 150 milligrams (mg) tablets) twice daily Other Name: Lynparza Drug: abiraterone acetate 1000 milligrams (mg) once daily Other Name: Zytiga |
Placebo Comparator: placebo plus abiraterone 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 1000 milligrams (mg) once daily Other Name: Zytiga |