NCT05471128

MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy

MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy for the Detection of Clinically Significant Prostate Cancer

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: Male
• Age: 18 Years – 99 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	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

Timeline

• Start date: 2023-01-27
• Primary completion: 2025-05-01
• Completion: 2026-06-01
• First posted: 2022-07-22
• Last updated: 2026-02-10

Locations

1 site across 1 country: United States