PROPEL: A randomized, phase III trial evaluating the efficacy and safety of olaparib combined with abiraterone as first-line therapy in patients with metastatic castration-resistant prostate cancer (mCRPC).

• DOI: 10.1200/jco.2019.37.7_suppl.tps340
• Publication Date: 2019-03-07T21:26:52Z
• Authors: Noel W. Clarke; Andrew J. Armstrong; Antoine Thiery-Vu...; Mototsugu Oya; Dingwei Ye; Joaquin Mateo; Carsten Dietrich ...; Jinyu Kang; Sherry Liu; Fred Saad
• Keywords: Olaparib; Clinical endpoint; Enzalutamide

TPS340 Background: A Phase II trial showed olaparib (tablets, 300 mg bid) in combination with abiraterone (1000 od plus prednisone/prednisolone 5 significantly prolonged radiologic progression-free survival (rPFS) compared alone (median 13.8 vs 8.2 months; hazard ratio 0.65, 95% CI 0.44–0.97, P=0.034) patients (pts) mCRPC the second-line metastatic setting who received prior docetaxel (Clarke et al. Lancet Oncol 2018). Treatment benefits were achieved irrespective of homologous recombination repair (HRR) mutation status, suggesting potential synergy between two treatments that could impact a broader patient population. PROpel (EudraCT: 2018-002011-10) is follow-on study to this, and first III assess PARP inhibitor as first-line treatment genetically unselected pt Methods: double-blind, placebo-controlled, international, multicenter pts randomized (1:1), for trial, either or placebo. Pts must not have chemotherapy, new hormonal agents other systemic at stage (except hormone-sensitive prostate cancer [mHSPC]). Randomization stratified according site metastases (bone only visceral other) mHSPC (yes, no). The primary endpoint investigator-assessed rPFS (RECIST v1.1 [soft tissue] Prostate Working Cancer Group 3 [PCWG-3 criteria; bone]). Secondary objectives include time subsequent therapy death, pain progression, overall survival, health-related quality life. Safety tolerability will also be described. Exploratory endpoints HRR subgroup analyses confirm efficacy independent status. Screening across ~200 sites 20 countries being conducted identify target sample ~720 pts. Enrollment expected begin October 2018. (Study 8, NCT01972217). Clinical information: NCT03732820.