Several new agents have been approved for CRPC, but we are still so far from being able to predict which group of patients might benefit from a particular strategy. Therefore, the identification of new predictive and prognostic biomarkers is urgently needed. In this setting, bone metabolism markers (BMM) assume particular importance regarding to R223.
PRORADIUM is a prospective multicentre observational study in metastatic CRPC designed to explore biomarkers in patients treated with R223. Key inclusion criteria: a) histological confirmation of prostate cancer; b) documented criteria (PCWG2) for CRPC; c) availability of tumour tissue; d) candidate for standard treatment with R223. Primary end point: to validate the prognostic value for overall survival (OS) of serum BMM expression described by Primo N Lara et al (JNCI 2014). Secondary end points: a) to analyse the prognostic role for PSA response regarding to BMM expression; b) to correlate radiological response with BMM; c) to investigate the association of skeletal related events with BMM; d) to analyse the prognostic role of alkaline phosphatase before and during R223; e) to analyse the prognostic value of “Bone Scan Index” in response evaluation; f) to analyse the prognostic role for OS of AR-V7 and AR amplification; g) to validate the prognostic role of the expression signature described by Olmos et al (Lancet Oncol 2012) in peripheral blood. Exploratory outcomes: a) to validate prognostic nomograms described for CRPC; b) to explore new somatic and germinal variants in peripheral blood and tissue associated to response and resistance to R223. PRORADIUM is part of the PROCURE Biomarkers network, a multicentric spanish platform for biomarkers discovery in CRPC patients. 161 patients will be accrued to provide appropriate statistical power to detect at least 85 events (deaths) to analyse the main outcome. Currently, 48 centres are active for recruitment and 54 patients have been included. Blood samples are collected before, during and after progression to R223. Prospective data collection will be linked. This study may help to incorporate new biomarkers in clinical practice and improve the selection of therapy in mCRPC.
Clinical trial identification
Legal entity responsible for the study
Spanish National Cancer Research Centre (CNIO)
Bayer Hispania, S.L
A. Medina: Honoraria from Bayer Hispania, S.L. All other authors have declared no conflicts of interest.