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MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy for the Detection of Clinically Significant Prostate Cancer
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).
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.
Age
18 - 99 years
Sex
MALE
Healthy Volunteers
No
University of Oklahoma Health Sciences Center, Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Start Date
January 27, 2023
Primary Completion Date
May 1, 2025
Completion Date
June 1, 2026
Last Updated
February 10, 2026
29
ACTUAL participants
Standard of Care Biopsy
PROCEDURE
Lead Sponsor
University of Oklahoma
NCT04550494
NCT05691465
Data Source & Attribution
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