Combination of Serum Measurements of Molecular Biomarkers and Serum Protein Profiling Can be Used to Predict Which Patients Undergoing Prostatic Biopsy Will be Diagnosed With Cancer
Stopped early · Not applicable
Conditions studied: Prostate Cancer, Elevated Prostate Specific Antigen (PSA)
In brief
This is a prospective, serum proteomics study of men who are to undergo prostate biopsy. The purpose is to determine if proteomic profiles can be used to distinguish between men with prostate cancer on biopsy from men with no cancer on biopsy.
Key facts
- Study ID
- NCT00773773
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 58
- Starts
- 2008-10-14
- Expected to finish
- 2024-03-08
- Last updated by the study team
- 2024-09-04
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Men aged 18 years or older
- Have a PSA level between 2 and 10 ng/ml
- May or may not have an abnormal digital rectal examination
- Scheduled for trans-rectal ultrasound (TRUS) guided systematic prostate biopsy as part of routine medical care. All sites (Department of Urology at SUNY Downstate Medical Center, Brooklyn, the Department of Urology, New York Presbyterian Hospital, Weill Medical College of Cornell University, Manhattan and the Department of Urology, Kings County Hospital) will perform a standardized 14 core biopsy protocol.
- Signed, informed consent
- Patient must be able to attend the pre-biopsy blood draw
You may not qualify if…
- Any period of prior/current treatment with hormonal therapy (LHRH agonist/antagonist,antiandrogen, 5-alpha-reductase inhibitor)
- Prior pelvic radiation
- A period of less than 6 months prior/current treatment with an alpha-blocker
- Previous diagnosis of prostate cancer
Where it is running
- Kings County Hopsital Center — Brooklyn, New York, United States
- SUNY Downstate Medical Center (DMC) — Brooklyn, New York, United States
- Memorial Sloan Kettering Cancer Center (All protocol activites) — New York, New York, United States
- Weill Medical College of Cornell University — New York, New York, United States
Full record on ClinicalTrials.gov
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