A Study to Assess if a Combination of Serum Measurements of Molecular Biomarkers and Serum Protein Profiling Can be Used to Predict Which Patients Undergoing Prostatic Biopsy Will be Diagnosed With Cancer
18 Years
N/A
Male
Prostate Cancer, Elevated Prostate Specific Antigen (PSA)
Trial Information
A Study to Assess if a Combination of Serum Measurements of Molecular Biomarkers and Serum Protein Profiling Can be Used to Predict Which Patients Undergoing Prostatic Biopsy Will be Diagnosed With Cancer
Inclusion Criteria:
- Men aged 18 years or older
- Have a PSA level between 2 and 10 ng/ml
- May or may not have an abnormal digital rectal examination
- Scheduled for trans-rectal ultrasound (TRUS) guided systematic prostate biopsy as
part of routine medical care. All sites (Department of Urology at SUNY Downstate
Medical Center, Brooklyn, the Department of Urology, New York Presbyterian Hospital,
Weill Medical College of Cornell University, Manhattan and the Department of Urology,
Kings County Hospital) will perform a standardized 14 core biopsy protocol.
- Signed, informed consent
- Patient must be able to attend the pre-biopsy blood draw
Exclusion Criteria:
- Any period of prior/current treatment with hormonal therapy (LHRH
agonist/antagonist,antiandrogen, 5-alpha-reductase inhibitor)
- Prior pelvic radiation
- A period of less than 6 months prior/current treatment with an alpha-blocker
- Previous diagnosis of prostate cancer
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
To determine if men with prostate cancer have a different proteomic profile than men without cancer. Cancer-free status will be confirmed by a re-biopsy at 6 months to reduce the biopsy false negative rate to less than 5 %.
Outcome Time Frame:
conclusion of study
Safety Issue:
No
Principal Investigator
Paul Tempst, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
08-114
NCT ID:
NCT00773773
Start Date:
October 2008
Completion Date:
October 2013
Related Keywords:
- Prostate Cancer
- Elevated Prostate Specific Antigen (PSA)
- Biomarkers - PSA, hK2 and solubilized
- urokinase-receptor forms (su-PAR)
- 08-114
- Prostatic Neoplasms
Name | Location |
|---|---|
| Weill Medical College of Cornell University | New York, New York 10021 |
| Kings County Hopsital Center | Brooklyn, New York |
| SUNY Downstate Medical Center (DMC) | Brooklyn, New York |
