Radiographic progression-free survival as a clinically meaningful end point in metastatic castration-resistant prostate cancer: The PREVAIL randomized clinical trial
JAMA Oncology Mar 14, 2018
Rathkopf DE, et al. - Radiographic progression-free survival (rPFS) as defined by the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) is a candidate end point that represents a clinically meaningful benefit to patients. Herein, the goal was to show the robustness of the PCWG2 definition and to assess the link between rPFS and overall survival (OS). The robustness of the PCWG2 rPFS definition was demonstrated, using additional measures of progression, in sensitivity analyses in PREVAIL, which is a phase 3, randomized, double-blind, placebo-controlled multinational study that enrolled chemotherapy-naive men with metastatic castration-resistant prostate cancer. Concordance was noted between central and investigator review. Furthermore, among enzalutamide-treated patients, a positive correlation was noted between rPFS and OS.
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