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

Clinical Evaluation of the PROGENSA(R) PCA3 Assay in Men With a Previous Negative Biopsy Result

The objective of this multi-center clinical study is to determine the association of the PCA3 Score with prostate biopsy outcome and validate the assay's performance characteristics in men with previous negative prostate biopsies. An elevated PCA3 Score is thought to be associated with an increased likelihood of positive biopsy. The results of this study are intended to be used for regulatory filings for use as an in vitro diagnostic test.

PCA3 is a gene that is highly over-expressed in more than 90% of prostate cancers, and that can be quantified in urine specimens following a digital rectal examination. Studies have shown that because PCA3 is highly specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional prostate-specific antigen (PSA) testing. Gen-Probe's PROGENSA(R) PCA3 assay is the first urine-based molecular diagnostic assay for prostate cancer.

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