Several novel therapeutic agents have demonstrated improvement of overall survival and further patient relevant endpoints in the setting of castration-resistant prostate cancer. Nevertheless, two questions have become increasingly relevant: are there any prognostic or predictive markers that could ease clinical decision-making using risk stratification and risk-adapted treatment in order to provide a benefit for the patient? Furthermore, against the background of increasing possibilities of therapy sequencing in clinical practice and in the clinical trial landscape in castration-resistant prostate cancer, does an isolated evaluation of overall survival reliably mirror the benefit attributable to a single compound? To address both these questions, suitable parameters serving as surrogates for intermediate and long-term endpoints and reflecting individual benefit, respectively, need to be identified and proven.
Keywords: biomarker; castration-resistant prostate cancer; clinical decision-making; clinical trials; predictive marker; prognostic marker; surrogate endpoint; surrogate marker.