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)

Protocol No
AZ-D081SC00001-PROPEL
Principal Investigator
Kathryn Bylow
Phase
III
Summary
In this study we want to find out if an experimental medication called olaparib in combination with approved drug called abiraterone, will work and be safe for the treatment of your disease (mCRPC). Olaparib is a type of drug called a PARP (poly [adenosine diphosphate-ribose] polymerase) inhibitor. PARP inhibitors can destroy cancer cells that are not good at repairing DNA damage. Olaparib (tradename Lynparza™) is approved by the US Food and Drug Administration (FDA) and other countries for the treatment of certain types of ovarian cancer and breast cancer. Abiraterone is already an approved medication for the treatment of some patients with prostate cancer. This medication is indicated in combination with prednisone or prednisolone for the treatment of mCRPC. A previous phase II study (small study with 142 participants) demonstrated that patients with mCRPC who were treated with chemotherapy (second-line setting) and olaparib plus abiraterone and prednisone or prednisolone remained progression free for a longer period of time compared to those who received placebo plus abiraterone and prednisone or prednisolone. This study will build on the knowledge gained from the phase II study described above to understand if the combination of olaparib plus abiraterone is better than abiraterone alone for the treatment of mCRPC.
Description
Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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