NCT06626022

Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging.

A Phase 3, Multicenter, International, Non-inferiority, Randomized Clinical Trial Comparing Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging (MUSIC-Screen)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,284 (estimated)
• Sponsor: University of Alberta · Academic / Other
• Sex: Male
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DEVICE	MRI	Standard prostate mpMRI.
DEVICE	ExactVu	microUltrasound

Timeline

• Start date: 2025-05-08
• Primary completion: 2029-11-30
• Completion: 2029-11-30
• First posted: 2024-10-03
• Last updated: 2026-04-06

Locations

6 sites across 4 countries: United States, Canada, France, Spain