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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gen-Probe, Incorporated
ClinicalTrials.gov Identifier:
NCT01024959
First received: December 1, 2009
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Prostatic Neoplasms
Other: PCA3 Assay

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of the PROGENSA(R) PCA3 Assay in Men With a Previous Negative Biopsy Result

Resource links provided by NLM:


Further study details as provided by Gen-Probe, Incorporated:

Primary Outcome Measures:
  • Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.) [ Time Frame: At the time of biopsy ] [ Designated as safety issue: No ]
    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


Enrollment: 507
Study Start Date: August 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PCA3 Assay Other: PCA3 Assay
Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy

Detailed 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024959

Locations
United States, California
HealthCare Partners Medical Group
Los Angeles, California, United States, 90015
San Diego Clinical Trials
San Diego, California, United States, 92120
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
Specialists in Urology
Naples, Florida, United States, 34102
Florida Urology Specialists
Sarasota, Florida, United States, 34237
United States, Indiana
Metropolitan Urology, PSC
Jeffersonville, Indiana, United States, 47130
United States, Louisiana
Regional Urology Specialists, LLC
Shreveport, Louisiana, United States, 71106
United States, New York
AccuMed Research Associates
Garden City, New York, United States, 11530
United States, Ohio
TriState Urologic Services PSC Inc. dba The Urology Group
Cincinnati, Ohio, United States, 45212
Columbus Urology Research, LLC
Columbus, Ohio, United States, 43220
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Urology San Antonio Research
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Urology
Richmond, Virginia, United States, 23235
Sponsors and Collaborators
Gen-Probe, Incorporated
Investigators
Study Director: Jennifer Reid, PhD Gen-Probe, Incorporated
  More Information

No publications provided by Gen-Probe, Incorporated

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gen-Probe, Incorporated
ClinicalTrials.gov Identifier: NCT01024959     History of Changes
Other Study ID Numbers: 2009PCA301
Study First Received: December 1, 2009
Results First Received: October 8, 2012
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Gen-Probe, Incorporated:
Prostate Cancer
Prostate Biopsy
PCA3

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014