Biomarkers in Patients Undergoing Transrectal Ultrasound Prostate Biopsy

Prostate Cancer Clinical Trial

Official title:

Biomarkers of Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373035
• Other study ID #: CCCWFU-85A03
• Secondary ID: CDR0000490117CCC
• Status: Completed
• Phase: N/A
• First received: September 6, 2006
• Last updated: January 17, 2017
• Start date: February 2006

Study information

• Verified date: June 2013
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Genetic:
• proteomic profiling

Other:
• immunological diagnostic method

• laboratory biomarker analysis

• mass spectrometry

Procedure:
• biopsy

• ultrasound imaging

Locations

Country	Name	City	State
United States	SurroMed Incorporated	Menlo Park	California
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unique proteins or peptides associated with prostate cancer