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

June 3, 2026 updated by: University of Alberta

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1284

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z1
        • Active, not recruiting
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Not yet recruiting
        • University of British Columbia
        • Principal Investigator:
          • Miles Mannas, MD
        • Contact:
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Principal Investigator:
          • Laurence Klotz, MD
        • Contact:
    • Quebec
      • Montréal, Quebec, Canada, H4J 1C5
  • France
      • Martigues, France
        • Recruiting
        • CH de Martigues
        • Principal Investigator:
          • Harry Toledano, MD
        • Contact:
  • Norway
      • Tønsberg, Norway
        • Recruiting
        • Vestfold Hospital Trust
        • Principal Investigator:
          • Sven Loffeler, PhD, MD
  • Spain
      • Bilbao, Spain
        • Recruiting
        • Urologia Clinica Bilbao
        • Contact:
        • Principal Investigator:
          • Felipe Urdaneta, MD
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Not yet recruiting
        • University of California, Los Angeles (UCLA)
        • Principal Investigator:
          • Wayne Brisbane, MD
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75390
        • Not yet recruiting
        • UT Southwestern Medical Center
        • Contact:
        • Principal Investigator:
          • Xiaosong Meng, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male sex;
  2. Age 50-70;
  3. PSA 3-20 and/or abnormal DRE;
  4. Biopsy naïve.

Exclusion Criteria:

  1. Prior personal history of prostate cancer;
  2. Prior prostate imaging using microUS or MRI;
  3. Contraindication to microUS or MRI;
  4. Testosterone replacement therapy within last 12 months; or
  5. Androgen deprivation therapy within last 12 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MRI
Device: MRI
Standard prostate mpMRI.
Experimental: microUltransound
Device: ExactVu
microUltrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of Clinically significant prostate cancer.
Time Frame: Once enrolled, men will be followed for 1 year after the imaging test.
The primary objective of this trial is to determine if a screening pathway using microUS is non-inferior to a pathway using MRI for the detection of clinically significant prostate cancer, defined as Gleason Grade Group 2 or more.
Once enrolled, men will be followed for 1 year after the imaging test.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Adam Kinnaird, MD, PhD, University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2025

Primary Completion (Estimated)

November 30, 2029

Study Completion (Estimated)

November 30, 2029

Study Registration Dates

First Submitted

October 1, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREBA.CC-24-0325

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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