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 study is currently recruiting participants.

Verified by Memorial Sloan-Kettering Cancer Center, October 2009

First Received: October 15, 2008 Last Updated: October 5, 2009 History of Changes

Sponsor:	Memorial Sloan-Kettering Cancer Center
Collaborators:	National Institutes of Health (NIH) New York Presbyterian Hospital Weill Medical College of Cornell University State University of New York - Downstate Medical Center New York University School of Medicine
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00773773

Purpose

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.

Condition	Intervention
Prostate Cancer Elevated Prostate Specific Antigen (PSA)	Other: serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays.

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment, Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine if Caucasian men and men of African-American descent with and without prostate cancer have different proteomic profiles. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
To assess reproducibility of proteomic profiles over different runs, platforms, and sites. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
To procure a DNA repository from these patients undergoing prostate biopsy for future assessment of kallikrein gene expression. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
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. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Patients undergoing prostatic biopsy: Experimental 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. 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.

Arms

Assigned Interventions

Patients undergoing prostatic biopsy: Experimental

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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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. Both sites (Department of Urology at SUNY Downstate Medical Center, Brooklyn and the Department of Urology, New York Presbyterian Hospital, Weill Medical College of Cornell University, Manhattan) 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773773

Locations

United States, New York
Weill Medical College of Cornell University	Recruiting
New York, New York, United States
Contact: Ming Ming Lee mil2022@med.cornell.edu
SUNY Downstate Medical Center (Brooklyn)	Recruiting
Brooklyn, New York, United States
Contact: Lorriane Thomas lorraine.thomas@downstate.edu

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Institutes of Health (NIH)

New York Presbyterian Hospital

Weill Medical College of Cornell University

State University of New York - Downstate Medical Center

New York University School of Medicine

Investigators

Principal Investigator:

Paul Tempst, PhD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Paul Tempst, PhD )
Study ID Numbers:	08-114
Study First Received:	October 15, 2008
Last Updated:	October 5, 2009
ClinicalTrials.gov Identifier:	NCT00773773 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Biomarkers - PSA, hK2 and solubilized
urokinase-receptor forms (su-PAR)

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010