Text Size

Biomarkers in Patients Undergoing Transrectal Ultrasound Prostate Biopsy

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00373035
First received: September 6, 2006
Last updated: November 20, 2009
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention
Prostate Cancer
 Genetic: proteomic profiling
Other: immunological diagnostic method
Other: laboratory biomarker analysis
Other: mass spectrometry
Procedure: biopsy
Procedure: ultrasound imaging

Study Type: Observational
Official Title: Biomarkers of Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Unique proteins or peptides associated with prostate cancer [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2006
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373035

Locations
United States, California
SurroMed Incorporated
Menlo Park, California, United States, 94025
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
National Cancer Institute (NCI)
Investigators
Study Chair: Frank M. Torti, MD, MPH Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00373035     History of Changes
Other Study ID Numbers: CDR0000490117, CCCWFU-85A03, CCCWFU-BG03-628
Study First Received: September 6, 2006
Last Updated: November 20, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
prostate cancer

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 22, 2013