PROfound — Olaparib in Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Repair Gene Alterations (PROfound)

Phase 3 · 2020 · Prostate Cancer

Design

Randomized open-label trial of olaparib versus physician's choice of enzalutamide or abiraterone.

Population

Metastatic castration-resistant prostate cancer with alterations in HRR genes (cohort A: BRCA1/2 or ATM), progressing on a prior novel hormonal agent.

Primary Endpoint

radiographic progression-free survival in cohort A

Key Result

In cohort A, rPFS 7.4 vs 3.6 months (HR 0.34) and overall survival 19.1 vs 14.7 months (HR 0.69) despite crossover.

Guideline Impact

NCCN category 1 olaparib for HRR-mutated (especially BRCA1/2) metastatic castration-resistant prostate cancer