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)
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.
Arms & interventions
- DeviceMRI
Standard prostate mpMRI.
- DeviceExactVu
microUltrasound
Outcome measures
Primary
Detection of Clinically significant prostate cancer.
The primary objective of this trial is to determine if a screening pathway using microUS is non-inferior to a pathway using MRI for the detection of clinically significant prostate cancer, defined as Gleason Grade Group 2 or more.
Time frame: Once enrolled, men will be followed for 1 year after the imaging test.
Eligibility criteria
Study locations (2)
University of California, Los Angeles (UCLA)
Los Angeles, California, 90095
UT Southwestern Medical Center
Dallas, Texas, 75390