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

Prostate Cancer Clinical Trial

— PReCISE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00966095
• Other study ID #: PReCISE
• Status: Active, not recruiting
• Phase: N/A
• First received: August 24, 2009
• Last updated: November 23, 2010
• Start date: December 2009

Study information

• Verified date: November 2010
• Source: Source MDx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University Brady Urological Institute	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital/ Dana Farber Cancer Institute	Boston	Massachusetts
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Urology Clinics of North Texas	Dallas	Texas
United States	The Urology Center of Colorado	Denver	Colorado
United States	Karmanos Cancer Institute Wayne State University	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Durham VA Medical Center	Durham	North Carolina
United States	Mount Sinai Medical Center	New York	New York
United States	University Urology Associates	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	Urology San Antonio Research	San Antonio	Texas
United States	San Bernardino Urological Associates	San Bernardino	California
United States	University of Washington Department of Urology	Seattle	Washington
United States	Bay State Clinical Trials	Watertown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Source MDx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ability of whole blood gene expression to predict biopsy outcome		pre-biopsy	No
Secondary	Prediction of tumor aggressiveness using whole blood gene expression		post-biopsy	No