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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 (PCA3)

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PCA3 Assay
Sponsored by
Gen-Probe, Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostatic Neoplasms focused on measuring Prostate Cancer, Prostate Biopsy, PCA3

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • HealthCare Partners Medical Group
  • San Diego Clinical Trials
  • South Florida Medical Research
  • Specialists in Urology
  • Florida Urology Specialists
  • Metropolitan Urology, PSC
  • Regional Urology Specialists, LLC
  • AccuMed Research Associates
  • TriState Urologic Services PSC Inc. dba The Urology Group
  • Columbus Urology Research, LLC
  • MD Anderson Cancer Center
  • Urology San Antonio Research
  • Virginia Urology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PCA3 Assay

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 1, 2009
Last Updated
November 6, 2012
Sponsor
Gen-Probe, Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01024959
Brief Title
Clinical Evaluation of the PROGENSA(Registered Trademark) Prostate Cancer Gene 3 (PCA3) Assay in Men With a Previous Negative Biopsy Result
Acronym
PCA3
Official Title
Clinical Evaluation of the PROGENSA(R) PCA3 Assay in Men With a Previous Negative Biopsy Result
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gen-Probe, Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Prostate Cancer, Prostate Biopsy, PCA3

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
507 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCA3 Assay
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
PCA3 Assay
Intervention Description
Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy
Primary Outcome Measure Information:
Title
Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.)
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
Time Frame
At the time of biopsy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Reid, PhD
Organizational Affiliation
Gen-Probe, Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
HealthCare Partners Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
Facility Name
San Diego Clinical Trials
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Specialists in Urology
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Florida Urology Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34237
Country
United States
Facility Name
Metropolitan Urology, PSC
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Regional Urology Specialists, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
AccuMed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
TriState Urologic Services PSC Inc. dba The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Columbus Urology Research, LLC
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43220
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Urology San Antonio Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Urology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23416644
Citation
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.
Results Reference
derived

Learn more about this trial

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

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