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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 January 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
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
Kings County Hospital
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00773773
First received: October 15, 2008
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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:

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 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients undergoing prostatic biopsy
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. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773773

Locations
United States, New York
SUNY Downstate Medical Center (DMC) Recruiting
Brooklyn, New York, United States
Contact: Lorriane Thomas         lorraine.thomas@downstate.edu    
Kings County Hopsital Center Recruiting
Brooklyn, New York, United States
Contact: Llewellyn Hyacinthe, MD     718-638-9222        
Weill Medical College of Cornell University Recruiting
New York, New York, United States
Contact: Sagit Goldberg         sag2020@med.cornell.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
Kings County Hospital
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
ClinicalTrials.gov Identifier: NCT00773773     History of Changes
Other Study ID Numbers: 08-114
Study First Received: October 15, 2008
Last Updated: January 31, 2013
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)
08-114

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013