PRostate Cancer Individual Signature Evaluation Trial in Patients Undergoing Scheduled Prostate Biopsy (PReCISE)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Source MDx.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Source MDx
Information provided by:
Source MDx
ClinicalTrials.gov Identifier:
NCT00966095
First received: August 24, 2009
Last updated: November 23, 2010
Last verified: November 2010
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Purpose
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 |
|---|
|
Prostate Cancer |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Source MDx:
Primary Outcome Measures:
- ability of whole blood gene expression to predict biopsy outcome [ Time Frame: pre-biopsy ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Prediction of tumor aggressiveness using whole blood gene expression [ Time Frame: post-biopsy ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
whole blood for gene expression analysis
serum
plasma
| Estimated Enrollment: | 1200 |
| Study Start Date: | December 2009 |
| Groups/Cohorts |
|---|
| men scheduled for prostate biopsy |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Men scheduled for a prostate biopsy
Criteria
Inclusion Criteria:.
- Male over the age of 40.
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%
- No prior history of prostate cancer or prostate biopsy.
Exclusion Criteria:
- Unable or unwilling to provide informed consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00966095
Locations
| 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 | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| University Urology Associates | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Durham VA Medical Center | |
| Durham, North Carolina, United States, 27705 | |
| 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
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Lisa Siconolfi, PhD, Director of Clinical Studies, Source MDx |
| ClinicalTrials.gov Identifier: | NCT00966095 History of Changes |
| Other Study ID Numbers: | PReCISE |
| Study First Received: | August 24, 2009 |
| Last Updated: | November 23, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Source MDx:
|
prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013