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

NCT ID: NCT01024959

Last Updated: 2012-11-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

507 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostatic Neoplasms

Keywords

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Prostate Cancer Prostate Biopsy PCA3

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PCA3 Assay

Group Type EXPERIMENTAL

PCA3 Assay

Intervention Type OTHER

Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy

Interventions

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PCA3 Assay

Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Gen-Probe, Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Reid, PhD

Role: STUDY_DIRECTOR

Gen-Probe, Incorporated

Locations

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HealthCare Partners Medical Group

Los Angeles, California, United States

Site Status

San Diego Clinical Trials

San Diego, California, United States

Site Status

South Florida Medical Research

Aventura, Florida, United States

Site Status

Specialists in Urology

Naples, Florida, United States

Site Status

Florida Urology Specialists

Sarasota, Florida, United States

Site Status

Metropolitan Urology, PSC

Jeffersonville, Indiana, United States

Site Status

Regional Urology Specialists, LLC

Shreveport, Louisiana, United States

Site Status

AccuMed Research Associates

Garden City, New York, United States

Site Status

TriState Urologic Services PSC Inc. dba The Urology Group

Cincinnati, Ohio, United States

Site Status

Columbus Urology Research, LLC

Columbus, Ohio, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Urology San Antonio Research

San Antonio, Texas, United States

Site Status

Virginia Urology

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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Gittelman MC, Hertzman B, Bailen J, Williams T, Koziol I, Henderson RJ, Efros M, Bidair M, Ward JF. PCA3 molecular urine test as a predictor of repeat prostate biopsy outcome in men with previous negative biopsies: a prospective multicenter clinical study. J Urol. 2013 Jul;190(1):64-9. doi: 10.1016/j.juro.2013.02.018. Epub 2013 Feb 14.

Reference Type DERIVED
PMID: 23416644 (View on PubMed)

Other Identifiers

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2009PCA301

Identifier Type: -

Identifier Source: org_study_id