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

NCT06626022

RecruitingPhase 3

Sponsor: University of Alberta

Conditions: Prostate Cancer Screening

Interventions: MRI, ExactVu

Countries: United States, Canada, France, Norway, Spain

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 overview

Sex: MALE

Age: 50 Years to 70 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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.
Locations (9)
  • Los Angeles, California, United States
  • Dallas, Texas, United States
  • Edmonton, Alberta, Canada
  • Vancouver, British Columbia, Canada
  • Toronto, Ontario, Canada
  • Montréal, Quebec, Canada
  • Martigues, France
  • Tønsberg, Norway
  • Bilbao, Spain