Serum Androgens as Predictors of Survival in Metastatic Prostate Cancer
Location(s): United States
The primary objective of this research is to demonstrate that serum androgen (SA) levels in patients with castration resistant prostate cancer (CRPC) are prognostic of overall survival (OS). A relationship of higher SA to improved survival has been observed in two phase III randomized studies, regardless of treatment arm, but never in a study in which an androgen synthesis inhibitor (ASI) such as abiraterone or ketoconazole was NOT part of the therapy. Patient serum is banked from CALGB 90401 - an NCI sponsored cooperative group randomized phase III that compared docetaxel plus prednisone (DP) to docetaxel/prednisone plus bevacizumab (DPB) in CRPC. Banked serum from this completed study will be used to measure androgen levels via CLIA certified ultrasensitive (liquid chromatography tandem mass spectroscopy) technique and these results will be associated with mature patient survival and outcome data. The underlying hypothesis of this work is that higher serum androgens are associated with improved outcomes, including survival, regardless of treatment, as it reflects a more favorable biological mileu in which the tumor remains partially dependent on androgens. We have the following specific aims:
AIM 1: To assess whether serum androgens (Androstenedione, DHEA-sulfate and Testosterone) using an ultrasensitive assay at baseline will be prognostic and predictive for clinical outcomes in mCRPC patients treated on CALGB 90401.