Clinical Validation of a Urinary Exosome Gene Signature in Men Presenting for Suspicion of Prostate Cancer

Inclusion Criteria:

1. Male, \>50 years of age with a clinical suspicion for prostate cancer based in part on an elevated PSA (limit range: 2.0 - 20 ng/ mL), and or suspicious DRE, with or without the clinical history of a single prior negative biopsy, and who have been recommended for a repeat and or first time biopsy.
2. The subject must be able to comprehend and sign an approved informed consent form and other applicable study documents.

Exclusion Criteria:

1. Use of medications or hormones that are known to affect serum PSA levels within 3-6 months of study enrollment.
2. Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment.
3. History of prostate cancer.
4. History of invasive treatments for benign prostatic hypertrophy (BPH) or lower urinary track symptoms within 6 months of study enrollment.
5. 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.
6. 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.
7. No known hepatitis (all types) and/or HIV documented in patient's medical record.
8. Patients with history of concurrent renal/bladder tumors within 6 months of study enrollment.