A cornerstone of the PCCTC’s research strategy is the co-development of therapies and biomarkers. To transform the clinical management of prostate cancer in the near term, it is essential to develop drugs in more precisely defined and biologically relevant patient groups. The ability to screen for patients most likely to respond to a novel agent is essential for both shortening development timelines and reducing exposure to unnecessary toxicity from ineffective treatment. Following the FDA’s Critical Path Initiative, we initiated one of the first endeavors in oncology to define blood and imaging-based biomarkers, develop analytically valid assays for them, and subsequently design and conduct the dedicated clinical trials necessary to establish their clinical validity. Capitalizing on the intellectual synergy of our investigators, our extensive clinical trial portfolio, and our many resources and basic science collaborations, our long-term objective is to establish intermediate or surrogate endpoints which can predict clinical benefit and form the basis for accelerated drug approvals.