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NCT06626022 | NOT YET RECRUITING | Prostate Cancer Screening

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

University of Alberta

Brief 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.

Condition or disease

Prostate Cancer Screening

Intervention/treatment

MRI

ExactVu

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 1284 participants
Masking : NONE
Primary Purpose : SCREENING
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)
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2029-11-30
Estimated Study Completion Date : 2029-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years to 70 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: 1
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.
Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging.

Location Details

NCT06626022

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Canada, Alberta

University of Alberta

Edmonton, Alberta, Canada, T6G 1Z1