ConfirmMDx Assay in Multiparametric MRI (mpMRI) PIRADS Scored Lesions After a Negative MR/US Fusion Biopsy
NCT ID: NCT03597386
Last Updated: 2019-03-01
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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WITHDRAWN
OBSERVATIONAL
2019-01-23
2019-01-24
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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All Participants
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* MRI lesion based on PIRADS scoring within the past 3 years
* Completed MR/US fusion prostate biopsy with concurrent systematic biopsy for PIRADS score 2-5 with negative pathological findings completed subsequent ConfirmMDx assay (regardless of result). The most recent biopsy can be within 4 years if ConfirmMDx already completed.
* May have had prior negative biopsy sessions prior to the most recent MR/US fusion biopsy
* Must be able to stop anticoagulation/antiplatelet therapy 5-7 days prior to obtaining biopsy
* Ability to give informed consent
Exclusion Criteria
* Any prostate cancer
* Active infection: urinary tract infection or prostate infection precluding prostate biopsy
* Anal stenosis or severe anal disease preventing prostate biopsy
18 Years
80 Years
MALE
No
Sponsors
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University of Rochester
OTHER
Responsible Party
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Hani Rashid
Professor, Urology
Locations
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University of Rochester Medical Center
Rochester, New York, United States
Countries
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Other Identifiers
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71689
Identifier Type: -
Identifier Source: org_study_id
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