• European urology · Jun 2021

    Editorial

    Untangling the PROfound Trial for Advanced Prostate Cancer: Is There Really a Role for Olaparib?

    • Daniel H Kwon, Christopher M Booth, and Vinay Prasad.
    • Division of Hematology/Oncology, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.
    • Eur. Urol. 2021 Jun 1; 79 (6): 710-712.

    AbstractThe phase 3 PROfound trial led to the recent approval of the PARP inhibitor olaparib for men with metastatic castration-resistant prostate cancer and mutations in homologous recombination repair genes. We raise methodological concerns about the trial, including: a suboptimal control arm, problematic use of crossover, use of radiographic progression-free survival as the primary endpoint, and ambiguous benefit for patients with mutations in homologous recombination repair genes other than BRCA1, BRCA2, and ATM.Copyright © 2021 European Association of Urology. Published by Elsevier B.V. All rights reserved.

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