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

Prostatic Neoplasms Clinical Trial

— PCA3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024959
• Other study ID #: 2009PCA301
• Status: Completed
• Phase: N/A
• First received: December 1, 2009
• Last updated: November 6, 2012
• Start date: August 2009
• Est. completion date: April 2010

Study information

• Verified date: November 2012
• Source: Gen-Probe, Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 507
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Other:
• PCA3 Assay
Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Gen-Probe, Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.)	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	At the time of biopsy	No