A Prospective, Multi-Center PRostate Cancer Individual Signature Evaluation Trial (PReCISE) in Patients Undergoing Scheduled Prostate Biopsy


N/A
40 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

A Prospective, Multi-Center PRostate Cancer Individual Signature Evaluation Trial (PReCISE) in Patients Undergoing Scheduled Prostate Biopsy


Inclusion Criteria:

.

1. Male over the age of 40.

2. Patient is scheduled for prostate biopsy for one or more of the following reasons:

- PSA > 2.5 ng/ml

- Rising PSA (>0.5 ng/ml/yr)

- Lower PSA value with other risk factors for prostate cancer (e.g.; family
history)

- Abnormal DRE

- Percent free PSA <15%

3. No prior history of prostate cancer or prostate biopsy.

Exclusion Criteria:

- Unable or unwilling to provide informed consent

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

ability of whole blood gene expression to predict biopsy outcome

Outcome Time Frame:

pre-biopsy

Safety Issue:

No

Principal Investigator

William Oh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mt. Sinai School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

PReCISE

NCT ID:

NCT00966095

Start Date:

December 2009

Completion Date:

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • Prostatic Neoplasms

Name

Location
University of Michigan Ann Arbor, Michigan  48109-0624
Mayo Clinic Rochester, Minnesota  55905
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Mount Sinai Medical Center New York, New York  10029
Urology San Antonio Research San Antonio, Texas  78229
Urology Clinics of North Texas Dallas, Texas  75231
Duke University Medical Center Durham, North Carolina  27710
University of Chicago Medical Center Chicago, Illinois  60637
San Bernardino Urological Associates San Bernardino, California  
Karmanos Cancer Institute Wayne State University Detroit, Michigan  48201
Durham VA Medical Center Durham, North Carolina  27705
University Urology Associates New York, New York  10016
The Urology Center of Colorado Denver, Colorado  80211
Johns Hopkins University Brady Urological Institute Baltimore, Maryland  21287
Brigham and Women's Hospital/ Dana Farber Cancer Institute Boston, Massachusetts  02115
Bay State Clinical Trials Watertown, Massachusetts  02472
University of Washington Department of Urology Seattle, Washington  98195