The purpose of this research study is investigate a new and validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy The current protocol has two objectives; one is to further assess and evaluate the performance of the urine test in men already scheduled for initial prostate needle biopsy (cohort (group) 1) and two, to evaluate how the results of the urine test influences the decision process for determining whether to perform a prostate biopsy (cohort (group) 2).
Inclusion Criteria: * 50 years of age * Clinical suspicion for prostate cancer * Elevated Prostate-specific antigen between: 2.0 - 10 ng/ mL * No clinical history of a prior negative biopsy Exclusion Criteria: * History of prior prostate biopsy. * Use of medications or hormones that are known to affect serum Prostate-specific antigen levels within 3-6 months of study enrollment. * Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment. * History of prostate cancer. * History of invasive treatments for benign prostatic hypertrophy (Benign Prostatic Hyperplasia) or lower urinary track symptoms within 6 months of study enrollment. * No known hepatitis (all types) and/or HIV documented in patient's medical record. * Patients with history of concurrent renal/bladder tumors.