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Biomarkers in Patients Undergoing Transrectal Ultrasound Prostate Biopsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00373035
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : January 19, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

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

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Official Title: Biomarkers of Prostate Cancer
Study Start Date : February 2006
Actual Primary Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00373035

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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)
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Study Chair: Frank M. Torti, MD, MPH Wake Forest University Health Sciences

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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) )
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: June 2013
Keywords provided by Wake Forest University Health Sciences:
prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases