RecruitingPhase 3NCT06626022

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)


Sponsor

University of Alberta

Enrollment

1,284 participants

Start Date

May 8, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 50 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study compares two imaging methods for prostate cancer screening: high-resolution micro-ultrasound and MRI (magnetic resonance imaging). Both are used to guide prostate biopsies, and researchers want to see which method is better at detecting cancer accurately. **You may be eligible if...** - You are a man between 50 and 70 years old - Your PSA (prostate-specific antigen) level is between 3 and 20, and/or you have an abnormal rectal exam - You have never had a prostate biopsy before **You may NOT be eligible if...** - You have a prior history of prostate cancer - You have already had prostate imaging with micro-ultrasound or MRI - You have had testosterone or hormone-blocking therapy in the past 12 months - You have a medical reason you cannot undergo micro-ultrasound or MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMRI

Standard prostate mpMRI.

DEVICEExactVu

microUltrasound


Locations(6)

University of California, Los Angeles (UCLA)

Los Angeles, California, United States

University of Alberta

Edmonton, Alberta, Canada

University of British Columbia

Vancouver, British Columbia, Canada

CIUSSS du Nord-de-l'Île-de-Montréal

Montréal, Quebec, Canada

CH de Martigues

Martigues, France

Urologia Clinica Bilbao

Bilbao, Spain

View Full Details on ClinicalTrials.gov

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NCT06626022


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