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

Not Applicable

Completed

Interventions: Other: serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays.

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Patients undergoing prostatic biopsy	serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays.	This study will enroll two groups of 250 patients who are to undergo prostatic biopsy as part of their routine medical care because of suspicion of prostate cancer (elevated PSA between 2 and 10 ng/ml, abnormal rectal examination, or both). The first group will contain 250 patients of African-American descent and the second will contain 250 Caucasian men.

Primary Outcome Measures

Name	Time	Method
To Determine if Men With Prostate Cancer Have a Different Proteomic Profile Than Men Without Cancer. Cancer-free Status Will be Confirmed by a Re-biopsy at 6 Months to Reduce the Biopsy False Negative Rate to Less Than 5 %.	conclusion of study
To Determine Whether the Peptide Proteomic Profile Can Improve the Predictive Ability of Known Serum Biomarkers (PSA (Free and Total), hK2 and Su-PAR) for Prostate Cancer.	conclusion of the study

Secondary Outcome Measures

Name	Time	Method
To Determine if Caucasian Men and Men of African-American Descent With and Without Prostate Cancer Have Different Proteomic Profiles.	conclusion of the study
To Assess Reproducibility of Proteomic Profiles Over Different Runs, Platforms, and Sites.	conclusion of the study
To Procure a DNA Repository From These Patients Undergoing Prostate Biopsy for Future Assessment of Kallikrein Gene Expression.	conclusion of the study
To Establish a Bank of DNA, Serum, and Frozen Lymphoblastoid Cells From These Patients for the Purpose of Enabling Genetic Investigations in Men With a Diagnosis of Prostate Cancer.	conclusion of the study

Locations (4): Kings County Hopsital Center
🇺🇸
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
SUNY Downstate Medical Center (DMC)
🇺🇸
Brooklyn, New York, United States

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