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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)

Trial Profile

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)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Mar 2025

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At a glance

  • Drugs Abiraterone acetate (Primary) ; Olaparib (Primary) ; Prednisolone; Prednisone
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms PROpel
  • Sponsors AstraZeneca; AstraZeneca AB
  • Most Recent Events

    • 04 Mar 2025 Planned End Date changed from 4 Nov 2024 to 27 Apr 2026.
    • 05 Sep 2024 According to a Foundation Medicine media release, The FDA has granted approval to FoundationOne CDx and FoundationOne Liquid CDx the approval of the companion diagnostics follows the 2023 FDA approval of olaparib in combination with abiraterone and prednisone or prednisolone in patients with BRCA-mutated metastatic CRPC based on results of the phase 3 PROpel trial.
    • 30 Jul 2024 Planned End Date changed from 28 Apr 2026 to 4 Nov 2024.

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