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

Status:	Active, not recruiting
Conditions:	Prostate Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	11/4/2018
Start Date:	October 14, 2008
End Date:	October 2019

A Study to Assess if a 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

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.

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:

- 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

We found this trial at

sites

SUNY Downstate Medical Center (DMC)

Brooklyn, New York

from

Brooklyn, NY