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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ACTIVE_NOT_RECRUITING
29 participants
OBSERVATIONAL
2023-01-27
2025-11-30
Brief Summary
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Detailed Description
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Enrolled patients will undergo MRI fusion biopsy and standard-template 12 core TRUS biopsy as the standard-of-care. Patients will also undergo micro-ultrasound evaluation and targeted biopsy if lesions are identified. Detection rates of clinically significant lesions by ExactVu and by MRI will be compared.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Standard of Care Biopsy
Patients will be evaluated with multiparametric MRI prostate followed by ExactVu micro-ultrasound to identify target lesions all of which will be biopsied by the examiner
Eligibility Criteria
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Inclusion Criteria
* Men with suspicion of prostate cancer
* Men on active surveillance
2. Age ≥18 \[30\]
3. Have available multiparametric prostate MRI
4. Able to provide written, informed consent
5. No significant medical illness which in the opinion of the Investigator would preclude entry to study procedures
6. Be willing and able to comply with scheduled visits
Exclusion Criteria
2. Unable to undergo prostate biopsy
3. Prostate MRI unable to be evaluated using the PI-RADS v2 criteria
4. Men with contraindication for MRI or a prostate biopsy
5. Prostate biopsy within 8 weeks prior to mpMRI.
6. Any history of prostate treatment
18 Years
99 Years
MALE
No
Sponsors
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University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Andrew McIntosh, MD
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma Stephenson Cancer Center
Locations
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University of Oklahoma Health Sciences Center, Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Countries
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Other Identifiers
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IRG-19-142-01
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
OU-SCC-PROBX
Identifier Type: -
Identifier Source: org_study_id
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