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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prostate Cancer, Elevated Prostate Specific Antigen (PSA)

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients undergoing prostatic biopsy<br>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. | Other: serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarkers - PSA, hK2 and solubilized, urokinase-receptor forms (su-PAR), 08-114