Biomarkers of Prostate Cancer
18 Years
N/A
Male
Prostate Cancer
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 Center | Winston-Salem, North Carolina 27157-1096 |
| SurroMed Incorporated | Menlo Park, California 94025 |
