PRostate Cancer Individual Signature Evaluation Trial in Patients Undergoing Scheduled Prostate Biopsy
NCT ID: NCT00966095
Last Updated: 2010-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
1200 participants
OBSERVATIONAL
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
men scheduled for prostate biopsy
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
40 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Source MDx
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Source MDx
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
William Oh, MD
Role: PRINCIPAL_INVESTIGATOR
Mt. Sinai School of Medicine
Danute "Bunki" Bankaitis-Davis, PhD
Role: PRINCIPAL_INVESTIGATOR
Source MDx
Lisa Siconolfi, PhD
Role: PRINCIPAL_INVESTIGATOR
Source MDx
Philip Kantoff, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
San Bernardino Urological Associates
San Bernardino, California, United States
The Urology Center of Colorado
Denver, Colorado, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Johns Hopkins University Brady Urological Institute
Baltimore, Maryland, United States
Brigham and Women's Hospital/ Dana Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Bay State Clinical Trials
Watertown, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Institute Wayne State University
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University Urology Associates
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Durham VA Medical Center
Durham, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Urology Clinics of North Texas
Dallas, Texas, United States
Urology San Antonio Research
San Antonio, Texas, United States
University of Washington Department of Urology
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PReCISE
Identifier Type: -
Identifier Source: org_study_id