Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging.
NCT06626022 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1284
Last updated 2026-04-06
Summary
The purpose of this study is to compare whether the FDA and Health Canada approved microUS is as effective as the currently used option (MRI) for imaging the prostate gland. Participants will be randomized into two groups to compare the imaging results of the current standard of care MRI and the new microUS. The study is looking to identify the most effective imaging modality to help guide whether you progress to have a prostate biopsy.
Conditions
- Prostate Cancer Screening
Interventions
- DEVICE
-
MRI
Standard prostate mpMRI.
- DEVICE
-
ExactVu
microUltrasound
Sponsors & Collaborators
-
University of Alberta
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SCREENING
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 70 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-05-08
- Primary Completion
- 2029-11-30
- Completion
- 2029-11-30
Countries
- United States
- Canada
- France
- Spain
Study Locations
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