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

40 Years
Not Enrolling
Prostatic Neoplasms

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Trial Information

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

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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.)

Outcome Description:

The likelihood of positive biopsy was determined by the PCA3 Score expressed as a binary categorical variable: PCA3 Score >=25 was positive, PCA3 Score <25 was negative

Outcome Time Frame:

At the time of biopsy

Safety Issue:


Principal Investigator

Jennifer Reid, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Gen-Probe, Incorporated


United States: Institutional Review Board

Study ID:




Start Date:

August 2009

Completion Date:

April 2010

Related Keywords:

  • Prostatic Neoplasms
  • Prostate Cancer
  • Prostate Biopsy
  • PCA3
  • Neoplasms
  • Prostatic Neoplasms



MD Anderson Cancer Center Houston, Texas  77030-4096
Urology San Antonio Research San Antonio, Texas  78229
South Florida Medical Research Aventura, Florida  33180
AccuMed Research Associates Garden City, New York  11530
Healthcare Partners Medical Group Torrance, California  90503
Columbus Urology Research, LLC Columbus, Ohio  43214
Metropolitan Urology, PSC Jeffersonville, Indiana  47130
Florida Urology Specialists Sarasota, Florida  34237
San Diego Clinical Trials San Diego, California  92120
Specialists in Urology Naples, Florida  34102
Regional Urology Specialists, LLC Shreveport, Louisiana  71106
TriState Urologic Services PSC Inc. dba The Urology Group Cincinnati, Ohio  45212
Virginia Urology Richmond, Virginia  23235