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Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging.
NCT06626022 · University of Alberta
In plain English
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Official title
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)
About this study
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 criteria
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 design
Enrollment target: 1284 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-05-08
Estimated completion: 2029-11-30
Last updated: 2026-04-06
Interventions
Device: MRIDevice: ExactVu
Primary outcomes
- • Detection of Clinically significant prostate cancer. (Once enrolled, men will be followed for 1 year after the imaging test.)
Sponsor
University of Alberta · other
Contacts & investigators
ContactAdam Kinnaird, MD, PhD · contact · ask@ualberta.ca · +1-780-407-5800
All locations (6)
University of California, Los Angeles (UCLA)Not Yet Recruiting
Los Angeles, California, United States
University of AlbertaRecruiting
Edmonton, Alberta, Canada
University of British ColumbiaNot Yet Recruiting
Vancouver, British Columbia, Canada
CIUSSS du Nord-de-l'Île-de-MontréalNot Yet Recruiting
Montréal, Quebec, Canada
CH de MartiguesRecruiting
Martigues, France
Urologia Clinica BilbaoRecruiting
Bilbao, Spain