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(Registered Trademark) Prostate Cancer Gene 3 (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