Biomarkers in Patients Undergoing Transrectal Ultrasound Prostate Biopsy

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00373035
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2006-07
• Study First Submitted: 2006-09-06
• Study First Submitted QC: 2006-09-06
• Study First Posted: 2006-09-07
• Status Verified: 2013-06
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Unique proteins or peptides associated with prostate cancer

Trial Locations

Locations (2)

SurroMed Incorporated; 🇺🇸 Menlo Park, California, United States

Wake Forest University Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States