Summary

Eligibility
for males ages 50-70 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

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)

Keywords

Prostate Cancer Screening, Prostatic Neoplasms, MRI, ExactVu, microUltransound

Eligibility

You can join if…

Open to males ages 50-70

  1. Male sex;
  2. Age 50-70;
  3. PSA 3-20 and/or abnormal DRE;
  4. Biopsy naïve.

You CAN'T join if...

  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

  • University of California, Los Angeles (UCLA)
    Los Angeles California 90095 United States
  • University of British Columbia
    Vancouver British Columbia V5Z 1M9 Canada
  • University of Alberta
    Edmonton Alberta T6G 1Z1 Canada
  • CIUSSS du Nord-de-l'Île-de-Montréal
    Montréal Quebec H4J 1C5 Canada

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of Alberta
ID
NCT06626022
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1284 study participants
Last Updated