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

Completed · Not applicable

Conditions studied: Prostatic Neoplasms

In brief

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.

Key facts

Study ID

NCT01024959

Run by

Gen-Probe, Incorporated

People needed

507

Starts

2009-08-01

Expected to finish

2010-04-01

Last updated by the study team

2012-11-12

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• HealthCare Partners Medical Group — Los Angeles, California, United States
• San Diego Clinical Trials — San Diego, California, United States
• South Florida Medical Research — Aventura, Florida, United States
• Specialists in Urology — Naples, Florida, United States
• Florida Urology Specialists — Sarasota, Florida, United States
• Metropolitan Urology, PSC — Jeffersonville, Indiana, United States
• Regional Urology Specialists, LLC — Shreveport, Louisiana, United States
• AccuMed Research Associates — Garden City, New York, United States
• TriState Urologic Services PSC Inc. dba The Urology Group — Cincinnati, Ohio, United States
• Columbus Urology Research, LLC — Columbus, Ohio, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Urology San Antonio Research — San Antonio, Texas, United States
• Virginia Urology — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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