Prospective study of a 17-GENE RT-PCR-based assay for prediction of high risk pathology at radical prostatectomy.

36Background: A biopsy-based 17 gene tissue-based RTPCR assay (Oncotype Dx Genomic Prostate Score, GPS) has been validated in retrospective cohorts as a predictor of adverse pathology and biochemical recurrence in prostate cancer (PCa) patients who underwent radical prostatectomy (RP). The National Comprehensive Cancer Network (NCCN) recommends that men with pathologic Gleason Score (pGS) > 8, pT3+, and/or Lymph Node positive disease (i.e. high risk surgical pathology, HRSP) consider adjuvant therapy after RP. We report herein on GPS at biopsy as a predictor of HRSP in men presenting with clinically low-risk PCa. Methods: As part of an ongoing observational study of GPS (N = 1200), we performed an exploratory analysis in men who elected RP as initial disease management. Descriptive statistics were reported. Binary logistic regression was performed to determine the association between GPS and HRSP. The odds ratio (OR) per 20 GPS units and 95% confidence interval (CI) were reported. All analyses were conduc...