Clinical Evaluation of the PROGENSA(Registered Trademark) Prostate Cancer Gene 3 (PCA3) Assay in Men With a Previous Negative Biopsy Result

Inclusion Criteria: * Men 40+ years of age who have had at least 1 previous negative prostate biopsy, who have never had a positive prostate biopsy, and who have been recommended for a repeat biopsy by their clinician. * The subject must be able to comprehend and sign an approved informed consent form and other applicable study enrollment documents Exclusion Criteria: * Use of medications or hormones that are known to affect serum PSA 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 (BPH) or lower urinary tract symptoms within 6 months of study enrollment * Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject * Participation in pharmaceutical or treatment related clinical study within 6 months of study enrollment. Exception: Trials for non-prostate conditions may be acceptable, with approval by the investigator and Sponsor