Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer
Summary
The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage.
Timeline
- Start
- 2018-10-31
- Primary completion
- 2021-07-30
- Completion
- 2027-02-05
Outcome
Met primary endpoint
paper PROpel met its primary endpoint showing statistically significant improvement in radiographic progression-free survival with olaparib plus abiraterone versus placebo plus abiraterone PMID 37714168 ↗
registry p <0.0001; Hazard Ratio (HR) 0.66 (95% CI 0.54 to 0.81) NCT03732820 ↗
release “PROpel trial, in which LYNPARZA in combination with abiraterone and prednisone demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint” merck.com ↗
release “In September 2021 at a planned interim analysis, the Independent Data Monitoring Committee concluded that the PROpel trial met the primary endpoint of rPFS.” astrazeneca.com ↗
release “In PROpel, LYNPARZA in combination with abiraterone and prednisone or prednisolone reduced the risk of disease progression or death by 34%” merck.com ↗
release “reduced the risk of disease progression or death by 34% (HR=0.66 [95% CI, 0.54-0.81]; p<0.0001)” merck.com ↗
release “Results from the PROpel trial showed a statistically significant and clinically meaningful 34% reduction in the risk of radiographic disease progression or death” astrazeneca.com ↗
release “there was a statistically significant improvement in rPFS in the full intention-to-treat (ITT) population in the PROpel trial” merck.com ↗
release “As previously reported, there was a statistically significant improvement in rPFS in the full intention-to-treat (ITT) population in the PROpel trial” merck.com ↗
release “PROpel試験において主要評価項目であるrPFSが達成された” msd.co.jp ↗
Publications
- Armstrong AJ, Saad F, Oya M, Shore N, Procopio G, Arslan C, Mehra N, Brown E, Joung JY, Sugimoto M, Ozguroglu M, Gedye C, Sartor O, Poehlein C, Qiu P, Liu YZ, Li X, Harrington EA, McGuinness D, Kang J, Barnicle A, Clarke N. Detection of Homologous Recombination Repair Gene Mutations by Tumor Tissue and Circulating Tumor DNA Testing in Prostate Cancer in the Phase III PROpel Trial. JCO Precis Oncol. 2026 May;10(5):e2501109. doi: 10.1200/PO-25-01109. Epub 2026 May 11.
- Armstrong AJ, Saad F, Oya M, Vianna K, Ozguroglu M, Gedye C, Buchschacher GL Jr, Lee JY, Emmenegger U, Navratil J, Virizuela JA, Salazar A, Maillet D, Uemura H, Hosius C, McGuinness D, Degboe A, Clarke N. Patient-reported Outcomes for Men with Metastatic Castration-resistant Prostate Cancer Who Received Olaparib plus Abiraterone Versus Placebo plus Abiraterone in the Phase 3 PROpel Study. Eur Urol Oncol. 2026 Feb;9(1):80-92. doi: 10.1016/j.euo.2025.09.010. Epub 2025 Nov 17.
- Oya M, Joung JY, Lee JY, Sugimoto M, Choi YD, Hong JH, Uemura H, Nishimura K, Tsumura H, Kawakami S, Hirayama Y, Kwon TG, Kwak C, Suzuki H, Fujita T, Nii M, McGuinness D, Dujka M, Poehlein C, Saad F, Clarke N. Olaparib Plus Abiraterone in Asian Patients With Metastatic Castration-Resistant Prostate Cancer: PROpel Subset Analysis. Cancer Sci. 2025 Jun;116(6):1638-1647. doi: 10.1111/cas.16459. Epub 2025 Mar 18.
- Heiss BL, Chang E, Gao X, Truong T, Brave MH, Bloomquist E, Shah A, Hamed S, Kraft J, Chiu HJ, Ricks TK, Tilley A, Pierce WF, Tang L, Abukhdeir A, Kalavar S, Philip R, Tang S, Pazdur R, Amiri-Kordestani L, Kluetz PG, Suzman DL. US Food and Drug Administration Approval Summary: Talazoparib in Combination With Enzalutamide for Treatment of Patients With Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2024 May 20;42(15):1851-1860. doi: 10.1200/JCO.23.02182. Epub 2024 Mar 7.
- Clarke NW, Armstrong AJ, Thiery-Vuillemin A, Oya M, Shore N, Loredo E, Procopio G, de Menezes J, Girotto G, Arslan C, Mehra N, Parnis F, Brown E, Schlurmann F, Joung JY, Sugimoto M, Virizuela JA, Emmenegger U, Navratil J, Buchschacher GL, Poehlein C, Harrington EA, Desai C, Kang J, Saad F. Abiraterone and Olaparib for Metastatic Castration-Resistant Prostate Cancer. NEJM Evid. 2022 Sep;1(9):EVIDoa2200043. doi: 10.1056/EVIDoa2200043. Epub 2022 Jun 3.
- Fallah J, Xu J, Weinstock C, Brave MH, Bloomquist E, Fiero MH, Schaefer T, Pathak A, Abukhdeir A, Bhatnagar V, Chiu HJ, Ricks T, John C, Hamed S, Lee C, Pierce WF, Kalavar S, Philip R, Tang S, Amiri-Kordestani L, Pazdur R, Kluetz PG, Suzman D. FDA Approval Summary: Olaparib in Combination With Abiraterone for Treatment of Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2024 Feb 10;42(5):605-613. doi: 10.1200/JCO.23.01868. Epub 2023 Dec 21.
- Saad F, Clarke NW, Oya M, Shore N, Procopio G, Guedes JD, Arslan C, Mehra N, Parnis F, Brown E, Schlurmann F, Joung JY, Sugimoto M, Sartor O, Liu YZ, Poehlein C, Barker L, Del Rosario PM, Armstrong AJ. Olaparib plus abiraterone versus placebo plus abiraterone in metastatic castration-resistant prostate cancer (PROpel): final prespecified overall survival results of a randomised, double-blind, phase 3 trial. Lancet Oncol. 2023 Oct;24(10):1094-1108. doi: 10.1016/S1470-2045(23)00382-0. Epub 2023 Sep 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olaparib | Small molecule | 300 mg | Oral |
| Background | Abiraterone acetate | Small molecule | 1000 mg | Oral |