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Biomarkers in Patients Undergoing Transrectal Ultrasound Prostate Biopsy

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences Identifier:
First received: September 6, 2006
Last updated: January 17, 2017
Last verified: June 2013

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:

Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Unique proteins or peptides associated with prostate cancer

Estimated Enrollment: 60
Study Start Date: February 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Detailed Description:



  • 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).


  • 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.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • No participation in another clinical trial within the past 30 days
  • No more than one enrollment into this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00373035

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 Health Sciences
National Cancer Institute (NCI)
Study Chair: Frank M. Torti, MD, MPH Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences Identifier: NCT00373035     History of Changes
Other Study ID Numbers: CCCWFU-85A03
CDR0000490117 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: September 6, 2006
Last Updated: January 17, 2017

Keywords provided by Wake Forest University Health Sciences:
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on September 21, 2017