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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: University of Alberta • ClinicalTrials.gov ID: NCT06626022

Registry updated: 2026-09-25
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Description

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.

Interventions

  • MRI (Device)
    Standard prostate mpMRI.
  • ExactVu (Device)
    microUltrasound

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.

Conditions

Prostate Cancer Screening

Locations

  • University of California, Los Angeles (UCLA) — Los Angeles, California, United States
  • UT Southwestern Medical Center — Dallas, Texas, United States
  • University of Alberta — Edmonton, Alberta, Canada
  • University of British Columbia — Vancouver, British Columbia, Canada
  • Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
  • CIUSSS du Nord-de-l'Île-de-Montréal — Montréal, Quebec, Canada
  • CH de Martigues — Martigues, France
  • Vestfold Hospital Trust — Tønsberg, Norway
  • Urologia Clinica Bilbao — Bilbao, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record