To improve treatments for patients with castration-resistant prostate cancer, new biomarkers and surrogate end points for clinical trials are required. Identifying biomarkers that reflect clinical benefit and that guide personalized treatment plans are of the highest priority. This Review article outlines the framework for developing such biomarkers, including analytical validation, clinical validation and regulatory approval, and describes promising emerging biomarkers.
- Howard I. Scher
- Michael J. Morris
- Glenn Heller