PRostate Cancer Individual Signature Evaluation Trial in Patients Undergoing Scheduled Prostate Biopsy
- Conditions
- Prostate Cancer
- Registration Number
- NCT00966095
- Lead Sponsor
- Source MDx
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 1200
.
-
Male over the age of 40.
-
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%
-
No prior history of prostate cancer or prostate biopsy.
- Unable or unwilling to provide informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ability of whole blood gene expression to predict biopsy outcome pre-biopsy
- Secondary Outcome Measures
Name Time Method Prediction of tumor aggressiveness using whole blood gene expression post-biopsy
Trial Locations
- Locations (17)
San Bernardino Urological Associates
🇺🇸San Bernardino, California, United States
Johns Hopkins University Brady Urological Institute
🇺🇸Baltimore, Maryland, United States
Brigham and Women's Hospital/ Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
The Urology Center of Colorado
🇺🇸Denver, Colorado, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Karmanos Cancer Institute Wayne State University
🇺🇸Detroit, Michigan, United States
University Urology Associates
🇺🇸New York, New York, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Washington Department of Urology
🇺🇸Seattle, Washington, United States
Bay State Clinical Trials
🇺🇸Watertown, Massachusetts, United States
Durham VA Medical Center
🇺🇸Durham, North Carolina, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Urology Clinics of North Texas
🇺🇸Dallas, Texas, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Urology San Antonio Research
🇺🇸San Antonio, Texas, United States