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