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

Memorial Sloan Kettering Cancer Center58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Prostate Cancer Elevated Prostate Specific Antigen (PSA)

Interventions

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

Patients referred for prostate biopsy as part of their routine care are to be recruited. Patients will undergo standard medical evaluation/care by undergoing a prostate biopsy because of an elevated PSA blood test and/or an abnormal digital rectal prostate examination. The protocol involves obtaining the research blood sample at the time of routine pre-biopsy blood draw. As such, an extra five (40 mL) tubes of blood will be drawn. The serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

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

Outcomes

Primary Outcomes

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 %.

Time frame: 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.