Status:
UNKNOWN
PRostate Cancer Individual Signature Evaluation Trial in Patients Undergoing Scheduled Prostate Biopsy
Lead Sponsor:
Source MDx
Conditions:
Prostate Cancer
Eligibility:
MALE
40+ years
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 redu...
Eligibility Criteria
Inclusion
- .
- 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.
Exclusion
- Unable or unwilling to provide informed consent
Key Trial Info
Start Date :
December 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00966095
Start Date
December 1 2009
Last Update
November 25 2010
Active Locations (17)
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1
San Bernardino Urological Associates
San Bernardino, California, United States, 92404
2
The Urology Center of Colorado
Denver, Colorado, United States, 80211
3
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
4
Johns Hopkins University Brady Urological Institute
Baltimore, Maryland, United States, 21287