Clinical trial NCT00966095: PRostate Cancer Individual Signature Evaluation Trial in Patients Undergoing Scheduled Prostate Biopsy
Official title: A Prospective, Multi-Center PRostate Cancer Individual Signature Evaluation Trial (PReCISE) in Patients Undergoing Scheduled Prostate Biopsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: prostate cancer
Lead sponsor: Source MDx
Sponsor class: INDUSTRY
First posted: 2009-08-26
Enrollment: 1200
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men scheduled for a prostate biopsy

Brief summary: The purpose of this study is to develop and validate a blood-based diagnostic test that will predict prostate biopsy outcome as positive or negative for prostate cancer. Such a test will serve to reduce the number of unnecessary prostate biopsies.


Eligibility criteria: Inclusion Criteria:.

1. Male over the age of 40.
2. Patient is scheduled for prostate biopsy for one or more of the following reasons:

   * PSA \> 2.5 ng/ml
   * Rising PSA (\>0.5 ng/ml/yr)
   * Lower PSA value with other risk factors for prostate cancer (e.g.; family history)
   * Abnormal DRE
   * Percent free PSA \<15%
3. No prior history of prostate cancer or prostate biopsy.

Exclusion Criteria:

* Unable or unwilling to provide informed consent

Primary outcomes:
measure: ability of whole blood gene expression to predict biopsy outcome
timeFrame: pre-biopsy
Secondary outcomes:
measure: Prediction of tumor aggressiveness using whole blood gene expression
timeFrame: post-biopsy
Other outcomes:
Locations:
city: San Bernardino
country: United States
facility: San Bernardino Urological Associates
state: California
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University Brady Urological Institute
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital/ Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Watertown
country: United States
facility: Bay State Clinical Trials
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute Wayne State University
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: University Urology Associates
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: Seattle
country: United States
facility: University of Washington Department of Urology
state: Washington
Study officials:
affiliation: Mt. Sinai School of Medicine
name: William Oh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Source MDx
name: Danute "Bunki" Bankaitis-Davis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Source MDx
name: Lisa Siconolfi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: Philip Kantoff, MD
role: PRINCIPAL_INVESTIGATOR
References: