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
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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
EXCLUSION CRITERIA
Exclusion Criteria:
- 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
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Prostate Cancer,Elevated Prostate Specific Antigen (PSA)
Age (in years)
18+
Phase
Not Applicable
Participants needed
500
Est. Completion Date
Oct 31, 2024
Treatment type
Interventional
Sponsor
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov identifier
NCT00773773
Study number
08-114
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