MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Status
RECRUITING
Phase
Age
18 - 99 Years
Enrollments
30Conditions
Prostate CancerSummary
The purpose of this study is to find out how best to detect clinically significant lesions of prostate cancer by using micro-ultrasound technology (ExactVu) and by multiparametric magnetic-resonance imaging (mpMRI).
Detailed Description
This is a pilot clinical trial with 30 patients with either: 1) suspected prostate cancer (based on elevated PSA or abnormal digital rectal exam (DRE), or 2) known low-risk prostate cancer being managed with active surveillance.
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Andrew McIntosh, MD
- 405-271-8001
- [email protected]
Principal Investigator
- Andrew McIntosh, MD
Eligibility Criteria
Inclusion Criteria:
1. Patients scheduled to undergo biopsy and with one of the following:
* 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:
1. Previously confirmed prostate cancer diagnosis with Grade Group >= 2
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
Outcome Measures
Primary Outcome Measures
Detection Rate
Feasibility of ExactVu
Secondary Outcome Measures
Predictive Performance Measures
Predictive Performance Measures
Timeline
Last Updated
February 15, 2024Start Date
July 22, 2022Today
January 16, 2025Completion Date ( Estimated )
June 1, 2025
Sponsors of this trial
Lead Sponsor
University of Oklahoma
RECRUITING 
21 - 64 Years