The objectives of the study include: ¿ To estimate the impact of a biopsy based genomic risk assessment tool (Prolaris®) on the magnitude of change between the PRE-Prolaris® test selection of treatment option for clinically localized prostate cancer and the ACTUAL implemented treatment administered following the genomic test results. To estimate the impact of a biopsy based genomic risk assessment tool (Prolaris®) on the magnitude of change between the PRE-Prolaris® test selection of treatment option for early-stage prostate cancer and the POSTProlaris ® test treatment plan following consultation with the patient. To estimate the impact of a biopsy based genomic risk assessment tool (Prolaris®) on the magnitude of change between physician's initial likelihood of recommending non-interventional therapy for early-stage prostate cancer and the likelihood following the genomic test results
Ascertain the impact of a low folate (folic acid) enriched diet- a reverse dietary intervention- on prostate cancer prevention and progression.
All care participants receive is Standard of Care for Active Surveillance. Research procedures include blood draw every 6 months for serum and plasma, urine collections, prostate tissue collection, Food & Supplement Use Questionnaire and the Health-Related Quality of Life Questionnaire. Purpose of the PASS is to understand how prostate cancer behaves and to find unique biomarkers (substances in blood, urine or tissue which can indicate the presence of cancer) associated with prostate cancer
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.