Clinical trial NCT01024959: Clinical Evaluation of the PROGENSA(Registered Trademark) Prostate Cancer Gene 3 (PCA3) Assay in Men With a Previous Negative Biopsy Result
Official title: Clinical Evaluation of the PROGENSA(R) PCA3 Assay in Men With a Previous Negative Biopsy Result
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Keywords: Prostate Cancer
Prostate Biopsy
PCA3
Lead sponsor: Gen-Probe, Incorporated
Sponsor class: INDUSTRY
First posted: 2009-12-03
Enrollment: 507
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.)
timeFrame: At the time of biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: HealthCare Partners Medical Group
state: California
city: San Diego
country: United States
facility: San Diego Clinical Trials
state: California
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Naples
country: United States
facility: Specialists in Urology
state: Florida
city: Sarasota
country: United States
facility: Florida Urology Specialists
state: Florida
city: Jeffersonville
country: United States
facility: Metropolitan Urology, PSC
state: Indiana
city: Shreveport
country: United States
facility: Regional Urology Specialists, LLC
state: Louisiana
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
city: Cincinnati
country: United States
facility: TriState Urologic Services PSC Inc. dba The Urology Group
state: Ohio
city: Columbus
country: United States
facility: Columbus Urology Research, LLC
state: Ohio
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
Study officials:
affiliation: Gen-Probe, Incorporated
name: Jennifer Reid, PhD
role: STUDY_DIRECTOR
References:
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.