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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

Primary Purpose

Prostate Cancer, Elevated Prostate Specific Antigen (PSA)

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays.
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Biomarkers - PSA, hK2 and solubilized, urokinase-receptor forms (su-PAR), 08-114

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kings County Hopsital Center
  • SUNY Downstate Medical Center (DMC)
  • Weill Medical College of Cornell University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients undergoing prostatic biopsy

Arm Description

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.

Outcomes

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 %.
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.

Secondary Outcome Measures

To determine if Caucasian men and men of African-American descent with and without prostate cancer have different proteomic profiles.
To assess reproducibility of proteomic profiles over different runs, platforms, and sites.
To procure a DNA repository from these patients undergoing prostate biopsy for future assessment of kallikrein gene expression.
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.

Full Information

First Posted
October 15, 2008
Last Updated
November 1, 2022
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, NYU Langone Health, Kings County Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00773773
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 14, 2008 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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, NYU Langone Health, Kings County Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Elevated Prostate Specific Antigen (PSA)
Keywords
Biomarkers - PSA, hK2 and solubilized, urokinase-receptor forms (su-PAR), 08-114

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients undergoing prostatic biopsy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays.
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
To assess reproducibility of proteomic profiles over different runs, platforms, and sites.
Time Frame
conclusion of the study
Title
To procure a DNA repository from these patients undergoing prostate biopsy for future assessment of kallikrein gene expression.
Time Frame
conclusion of the study
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Tempst, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kings County Hopsital Center
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
SUNY Downstate Medical Center (DMC)
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center

Learn more about this trial

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

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