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Biomarkers of Prostate Cancer


N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Biomarkers of Prostate Cancer


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Unique proteins or peptides associated with prostate cancer

Safety Issue:

No

Principal Investigator

Frank M. Torti, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Federal Government

Study ID:

CCCWFU-85A03

NCT ID:

NCT00373035

Start Date:

February 2006

Completion Date:

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • Prostatic Neoplasms

Name

Location

Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
SurroMed IncorporatedMenlo Park, California  94025