Research Information System
EUROPEAN UROLOGY ONCOLOGY, vol.9, no.1, pp.80-92, 2026 (SCI-Expanded, Scopus)
Background and objective: The phase 3 PROpel study showed a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) with olaparib + abiraterone versus placebo + abiraterone in the first-line setting for patients with metastatic castration-resistant prostate cancer (mCRPC) unselected by mutation status for homologous recombination repair genes. Here we report patient-reported outcomes and results for other symptom-related endpoints. Methods: Patients were randomized 1:1 to either olaparib (300 mg twice daily) or placebo, both given with abiraterone acetate (1000 mg once daily) plus prednisone or prednisolone. The primary endpoint was rPFS (at planned primary analysis; data cutoff July 30, 2021). Prespecified secondary endpoints included patient-reported outcomes evaluating health-related quality of life (HRQoL; Functional Assessment of Cancer Therapy-Prostate [FACT-P]) and pain (Brief Pain Inventory-Short Form [BPI-SF]) (prespecified final analysis of overall survival; data cutoff October 12, 2022). Key findings and limitations: Between October 31, 2018 and March 11, 2020, 1103 patients were screened, of whom 399 were randomized to olaparib + abiraterone and 397 to placebo + abiraterone. There were no overall differences between the treatment arms in the least-squares mean change from baseline in FACT-P total score or subscales, or in BPI-SF scores for worst pain, pain severity, and pain interference. Conclusions and clinical implications: In PROpel, there were no differences in HRQoL or pain scores reported by patients with mCRPC receiving olaparib + abiraterone versus placebo + abiraterone, suggesting that patients can derive a clinical benefit from olaparib + abiraterone while maintaining similar HRQoL in comparison with current standard-of-care treatment. The PROpel trial is registered on ClinicalTrials.gov as NCT03732820. (c) 2025 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY license (http://creativecommons. org/licenses/by/4.0/).