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Biomarkers in Patients Undergoing Transrectal Ultrasound Prostate Biopsy

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
proteomic profiling
immunological diagnostic method
laboratory biomarker analysis
mass spectrometry
biopsy
ultrasound imaging
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Prostate Cancer focused on measuring prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Indication for a transrectal ultrasonography prostatic biopsy (as part of normal patient care) due to elevated prostate-specific antigen, or abnormal digital rectal examination, or surveillance for prostate cancer

PATIENT CHARACTERISTICS:

  • No prior or other concurrent malignancy except for curatively treated basal cell carcinoma of the skin
  • No serious medical or psychiatric illness that would preclude informed consent
  • No concurrent acute illness

PRIOR CONCURRENT THERAPY:

  • No participation in another clinical trial within the past 30 days
  • No more than one enrollment into this study

Sites / Locations

  • SurroMed Incorporated
  • Wake Forest University Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Unique proteins or peptides associated with prostate cancer

Secondary Outcome Measures

Full Information

First Posted
September 6, 2006
Last Updated
January 17, 2017
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00373035
Brief Title
Biomarkers in Patients Undergoing Transrectal Ultrasound Prostate Biopsy
Official Title
Biomarkers of Prostate Cancer
Study Type
Observational

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Collecting and storing samples of blood and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is looking at biomarkers in patients undergoing transrectal ultrasound prostate biopsy.
Detailed Description
OBJECTIVES: Primary Identify unique proteins or peptides that are associated with prostate cancer by comparing the proteomic or metabolomic analysis of serum, plasma, and urine from patients with histological evidence of prostate cancer to those without prostate cancer (after transrectal ultrasound prostatic biopsy). Secondary Collect seminal fluid from a subset of patients to test the hypothesis that the fluid collected from the "target organ of injury" in prostate cancer will have a higher signal of proteins/peptides that are different from those without cancer and may help guide the identification of these differences in the serum, plasma, and urine. OUTLINE: This is a pilot study. Patients undergo collection of serum, plasma, and urine for biomarker/laboratory analysis. Samples are examined by proteomic/metabolomic analysis (by mass spectrometry) and immunoassays. Patients then undergo a transrectal ultrasonography prostatic biopsy. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer

7. Study Design

Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
proteomic profiling
Intervention Type
Other
Intervention Name(s)
immunological diagnostic method
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
mass spectrometry
Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Type
Procedure
Intervention Name(s)
ultrasound imaging
Primary Outcome Measure Information:
Title
Unique proteins or peptides associated with prostate cancer

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Indication for a transrectal ultrasonography prostatic biopsy (as part of normal patient care) due to elevated prostate-specific antigen, or abnormal digital rectal examination, or surveillance for prostate cancer PATIENT CHARACTERISTICS: No prior or other concurrent malignancy except for curatively treated basal cell carcinoma of the skin No serious medical or psychiatric illness that would preclude informed consent No concurrent acute illness PRIOR CONCURRENT THERAPY: No participation in another clinical trial within the past 30 days No more than one enrollment into this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank M. Torti, MD, MPH
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
SurroMed Incorporated
City
Menlo Park
State/Province
California
ZIP/Postal Code
94025
Country
United States
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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Biomarkers in Patients Undergoing Transrectal Ultrasound Prostate Biopsy

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