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
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RECRUITING
950 participants
OBSERVATIONAL
2019-02-04
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Initial prostate biopsy
Men who have never had a prostate biopsy, but have an elevated risk for prostate cancer such as elevated PSA who are scheduled or considered candidate for an initial prostate biopsy.
MRI prostate
MRI and laboratory biomarkers
Interventions
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MRI prostate
MRI and laboratory biomarkers
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* To be scheduled/scheduled for biopsy as routine clinical care
Exclusion Criteria
* Unable to undergo/tolerate a prostate MRI or failure to conduct the MRI
* Prior diagnosis of prostate cancer
* Prior prostate MRI unless being used as Index MRI (in this case index MRI can be one year prior to consent date)
* Participating in clinical trial for prostate disease
* Prior prostate surgery such as TURP, TUNA, TUMT, HOLEP, REZUM, UROlift
* Prior PCA3, TMPRSS2:erg or MIPS panel performed for clinical purpose
18 Years
MALE
No
Sponsors
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The University of Texas Health Science Center at San Antonio
OTHER
University of Alabama at Birmingham
OTHER
University of Chicago
OTHER
Cornell University
OTHER
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Vanderbilt University
OTHER
Emory University
OTHER
University of Miami
OTHER
University of Texas
OTHER
Beth Israel Deaconess Medical Center
OTHER
Brigham and Women's Hospital
OTHER
Fred Hutchinson Cancer Center
OTHER
University of Michigan
OTHER
Responsible Party
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John Wei
David A Bloom Professor of Urology, Medical Director of Brighton Center for Specialty Care and Professor of Urology, Medical School
Principal Investigators
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John T Wei, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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430
Identifier Type: -
Identifier Source: org_study_id
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