Clinical Evaluation of the PROGENSA(Registered Trademark) Prostate Cancer Gene 3 (PCA3) Assay in Men With a Previous Negative Biopsy Result
PCA3
1 other identifier
interventional
507
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2009
Shorter than P25 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 1, 2009
CompletedFirst Posted
Study publicly available on registry
December 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
November 7, 2012
CompletedNovember 12, 2012
November 1, 2012
8 months
December 1, 2009
October 8, 2012
November 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
PCA3 Assay
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
HealthCare Partners Medical Group
Los Angeles, California, 90015, United States
San Diego Clinical Trials
San Diego, California, 92120, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Specialists in Urology
Naples, Florida, 34102, United States
Florida Urology Specialists
Sarasota, Florida, 34237, United States
Metropolitan Urology, PSC
Jeffersonville, Indiana, 47130, United States
Regional Urology Specialists, LLC
Shreveport, Louisiana, 71106, United States
AccuMed Research Associates
Garden City, New York, 11530, United States
TriState Urologic Services PSC Inc. dba The Urology Group
Cincinnati, Ohio, 45212, United States
Columbus Urology Research, LLC
Columbus, Ohio, 43220, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Urology San Antonio Research
San Antonio, Texas, 78229, United States
Virginia Urology
Richmond, Virginia, 23235, United States
Related Publications (1)
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.
PMID: 23416644DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer Reid, Director of Clinical Affairs
- Organization
- Gen-Probe, Incorporated
Study Officials
- STUDY DIRECTOR
Jennifer Reid, PhD
Gen-Probe, Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2009
First Posted
December 3, 2009
Study Start
August 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
November 12, 2012
Results First Posted
November 7, 2012
Record last verified: 2012-11