Drug development for noncastrate prostate cancer in a changed therapeutic landscape

Clinical trials are an essential aspect of drug development; however, in patients with non-castrate prostate cancer, the long natural history of the disease provides a major barrier to the introduction of new therapies. In this Review, the authors describe the potential of a novel, multi-arm, multistage, clinical trial project, with surrogate end points designed to fully reflect the effects of treatments, in transforming the treatment of patients with early stage prostate cancer, before the development of castration-resistant disease.