Clinical development of novel therapeutics for castration‐resistant prostate cancer

Abstract

There have been more drugs approved by the US Food and Drug Administration for the treatment of castration‐resistant prostate cancer in the past 3 years than in the prior 3 decades, with additional drugs on the verge of approval based on the results of recently reported randomized trials. While an improvement in the understanding of the pathogenesis of castration‐resistant prostate cancer has undeniably accelerated the transition of novel approaches from “bench to bedside,” the recent successes in the treatment of prostate cancer are also a result of the efforts of clinical investigators to redefine the framework in which drugs for castration‐resistant disease are evaluated. This review will explore the shifting paradigm in drug development for castration‐resistant prostate cancer over the past several decades, and highlight how new definitions, trial designs, and endpoints have facilitated the emergence of new therapies for this challenging disease. CA Cancer J Clin 2012;. © 2012 American Cancer Society.