Efficacy and Safety of Olaparib plus Abiraterone Versus Placebo plus Abiraterone in the Non-BRCA Mutation Subgroup of Patients with Metastatic Castration-resistant Prostate Cancer in the PROpel Trial.

Authors

Niven Mehra, Noel W Clarke, Andrew J Armstrong, Mototsugu Oya, Neal Shore, Giuseppe Procopio, João Daniel Guedes, Cagatay Arslan, Emma Brown, Jae Young Joung, Mikio Sugimoto, Young Deuk Choi, Daniel Castellano, Yüksel Ürün, Christian Hosius, David McGuinness, Arnold Degboe, Fred Saad

Published in

European urology oncology. Oct 05, 2026. Epub Oct 05, 2026.

Abstract

The phase 3 PROpel trial (NCT03732820) demonstrated statistically significant and clinically meaningful radiographic progression-free survival (rPFS) benefit and numerically prolonged overall survival (OS) for olaparib plus abiraterone versus placebo plus abiraterone in first-line metastatic castration-resistant prostate cancer (mCRPC). The greatest benefit was in patients with a BRCA1 and/or BRCA2 mutation (BRCAm).
To inform treatment decision-making, we report analyses in the non-BRCAm subgroup in PROpel.
Patients were randomized (1:1) to olaparib plus abiraterone with prednisone/prednisolone versus placebo plus abiraterone with prednisone/prednisolone. Patients without BRCAm were classified as having no positive BRCAm result by at least one prespecified tumour tissue or circulating tumour DNA test. Post hoc exploratory analyses included rPFS, OS, additional efficacy end points, health-related quality of life (HRQoL), and safety.
Median investigator-assessed rPFS in the non-BRCAm subgroup (n = 693) was 24.1 mo for olaparib plus abiraterone versus 19.0 mo for placebo plus abiraterone (hazard ratio [HR] 0.76, 95% confidence interval [CI] 0.61-0.94). Median OS was 39.6 versus 38.0 mo, respectively (HR 0.91, 95% CI 0.73-1.13). Additional post hoc exploratory analyses support these efficacy findings for olaparib plus abiraterone. There was no significant difference in HRQoL between treatment arms. Safety findings were consistent with the overall biomarker-unselected population.
Olaparib plus abiraterone provided numerically longer rPFS versus placebo plus abiraterone, with no new safety signals, in the non-BRCAm subgroup of patients with mCRPC in PROpel. Our findings support olaparib plus abiraterone as an important new treatment option for consideration in patients with non-BRCAm mCRPC.

PMID:
42833926
Bibliographic data and abstract were imported from PubMed on 06 Oct 2026.

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