PROfound: Phase III study of olaparib versus enzalutamide or abiraterone for metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair (HRR) gene alterations

Abstract

Background: Loss-of-function alterations in HRR genes are associated with response to PARP inhibition. PROfound (NCT02987543) is a randomized, open-label, phase III trial evaluating efficacy and safety of olaparib (ola) vs enzalutamide (enza) or abirater-one (abi) in patients (pts) with mCRPC with alterations in any of 15 predefined genes with a direct or indirect role in HRR whose disease had progressed on prior new hormonal agent (NHA) therapy. Methods: Qualifying tumour tissue HRR alterations were centrally and prospectively identified using an investigational next-generation sequencing test (Foundation