MP24-04 A 2-GENE MRNA URINE TEST FOR DETECTION OF HIGH-GRADE PROSTATE CANCER PRIOR TO INITIAL PROSTATE BIOPSY

INTRODUCTION AND OBJECTIVES:A 2-gene, urine-based molecular test that combines mRNA biomarkers with clinical factors can risk stratify patients for high-grade prostate cancer (PCa). To ensure the generalizability of the risk score, the model was optimized and validated for patients from three European countries who were undergoing initial prostate biopsy.METHODS:The study population consisted of 1956 men suspected of PCa from The Netherlands, France and Germany who underwent initial prostate biopsies between December 2007 and December 2014. The median age was 65 years (interquartile range 60-70), median serum PSA 6.3 ng/mL (IQR 4.5-9.3) and 485/1956 (25%) had abnormal DRE results. PCa was detected in 991/1956 (51%) men biopsied: 46% ISUP grade group (GG) 1, 27% GG2, 12% GG3, 7% GG4 and 8% GG5. The prevalence of GG2-5 PCa was 27.6% (540/1956).Post-DRE urine was collected from all subjects prior to biopsy, and samples were stored at -700C. Urinary HOXC6 and DLX-1 mRNAs were quantified by PCR (MDxHealth, Irv...