NCT06626022PHASE3RecruitingAccepts Healthy Volunteers

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

University of Alberta

Start Date

5/8/2025

Completion Date

11/30/2029

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 Criteria

Age Range: 50 years to 70 years

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.

Interventions

DEVICE

MRI

DEVICE

ExactVu

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Conditions

Prostate Cancer Screening

Locations

University of California, Los Angeles (UCLA)

Los Angeles, California 90095

United States

UT Southwestern Medical Center

Dallas, Texas 75390

United States

University of Alberta

Edmonton, Alberta T6G 1Z1

Canada

University of British Columbia

Vancouver, British Columbia V5Z 1M9

Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario M4N 3M5

Canada

CIUSSS du Nord-de-l'Île-de-Montréal

Montréal, Quebec H4J 1C5

Canada

CH de Martigues

Martigues,

France

Vestfold Hospital Trust

Tønsberg,

Norway

Urologia Clinica Bilbao

Bilbao,

Spain