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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 MichiganAnn Arbor, Michigan  48109-0624
Mayo ClinicRochester, Minnesota  55905
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Mount Sinai Medical CenterNew York, New York  10029
Urology San Antonio ResearchSan Antonio, Texas  78229
Urology Clinics of North TexasDallas, Texas  75231
Duke University Medical CenterDurham, North Carolina  27710
University of Chicago Medical CenterChicago, Illinois  60637
San Bernardino Urological AssociatesSan Bernardino, California  
Karmanos Cancer Institute Wayne State UniversityDetroit, Michigan  48201
Durham VA Medical CenterDurham, North Carolina  27705
University Urology AssociatesNew York, New York  10016
The Urology Center of ColoradoDenver, Colorado  80211
Johns Hopkins University Brady Urological InstituteBaltimore, Maryland  21287
Brigham and Women's Hospital/ Dana Farber Cancer InstituteBoston, Massachusetts  02115
Bay State Clinical TrialsWatertown, Massachusetts  02472
University of Washington Department of UrologySeattle, Washington  98195