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)
University of Alberta
1,284 participants
May 8, 2025
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
Inclusion Criteria4
- Male sex;
- Age 50-70;
- PSA 3-20 and/or abnormal DRE;
- Biopsy naïve.
Exclusion Criteria5
- Prior personal history of prostate cancer;
- Prior prostate imaging using microUS or MRI;
- Contraindication to microUS or MRI;
- Testosterone replacement therapy within last 12 months; or
- Androgen deprivation therapy within last 12 months.
Interventions
Standard prostate mpMRI.
microUltrasound
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06626022