PRostate Cancer Individual Signature Evaluation Trial in Patients Undergoing Scheduled Prostate Biopsy (PReCISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00966095
Recruitment Status : Unknown
Verified November 2010 by Source MDx.
Recruitment status was:  Active, not recruiting
First Posted : August 26, 2009
Last Update Posted : November 25, 2010
Information provided by:
Source MDx

Brief Summary:
The purpose of this study is to develop and validate a blood-based diagnostic test that will predict prostate biopsy outcome as positive or negative for prostate cancer. Such a test will serve to reduce the number of unnecessary prostate biopsies.

Condition or disease
Prostate Cancer

Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Prospective, Multi-Center PRostate Cancer Individual Signature Evaluation Trial (PReCISE) in Patients Undergoing Scheduled Prostate Biopsy
Study Start Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

men scheduled for prostate biopsy

Primary Outcome Measures :
  1. ability of whole blood gene expression to predict biopsy outcome [ Time Frame: pre-biopsy ]

Secondary Outcome Measures :
  1. Prediction of tumor aggressiveness using whole blood gene expression [ Time Frame: post-biopsy ]

Biospecimen Retention:   Samples Without DNA

whole blood for gene expression analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men scheduled for a 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00966095

United States, California
San Bernardino Urological Associates
San Bernardino, California, United States, 92404
United States, Colorado
The Urology Center of Colorado
Denver, Colorado, United States, 80211
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins University Brady Urological Institute
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Brigham and Women's Hospital/ Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Bay State Clinical Trials
Watertown, Massachusetts, United States, 02472
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48105
Karmanos Cancer Institute Wayne State University
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
University Urology Associates
New York, New York, United States, 10016
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
Urology Clinics of North Texas
Dallas, Texas, United States, 75231
Urology San Antonio Research
San Antonio, Texas, United States, 78229
United States, Washington
University of Washington Department of Urology
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Source MDx
Principal Investigator: William Oh, MD Mt. Sinai School of Medicine
Principal Investigator: Danute "Bunki" Bankaitis-Davis, PhD Source MDx
Principal Investigator: Lisa Siconolfi, PhD Source MDx
Principal Investigator: Philip Kantoff, MD Dana-Farber Cancer Institute

Responsible Party: Lisa Siconolfi, PhD, Director of Clinical Studies, Source MDx Identifier: NCT00966095     History of Changes
Other Study ID Numbers: PReCISE
First Posted: August 26, 2009    Key Record Dates
Last Update Posted: November 25, 2010
Last Verified: November 2010

Keywords provided by Source MDx:
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases