Clinical Evaluation of the ExoDx Prostate (IntelliScore) in men presenting for initial biopsy: impact on decision-making and health economics (CTMS 16-0040)
1.1. Primary Objective 1.1.1. Evaluate impact of the ExoIntelliScore Prostate on the decision to perform an initial prostate biopsy for men presenting with an elevated PSA (2-10 ng/mL). 1.2. Secondary and Exploratory Objectives 1.2.1. Assess physician satisfaction with the ExoIntelliScore Prostate report including test result presentation, graphics and interpretation. 1.2.2. Assess patient satisfaction for ease of understanding test results and role on decision process to have a biopsy. 1.2.3. Determine the medical economic impact of the ExoIntelliScore Prostate in the prostate biopsy decision process. 1.2.4. Correlation of the ExoIntelliScore Prostate score with the actual biopsy result. 1.2.5. The goal of this study is to evaluate how the urologist will utilize the ExoIntelliScore Prostate score in the decision process to perform an initial prostate needle biopsy for men presenting for an equivocal PSA.