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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
1,284
Standard prostate mpMRI.
microUltrasound
University of California, Los Angeles (UCLA)
Los Angeles, California, United States
NOT_YET_RECRUITINGUniversity of Alberta
Edmonton, Alberta, Canada
RECRUITINGUniversity of British Columbia
Vancouver, British Columbia, Canada
NOT_YET_RECRUITINGCIUSSS du Nord-de-l'Île-de-Montréal
Montréal, Quebec, Canada
NOT_YET_RECRUITINGCH de Martigues
Martigues, France
RECRUITINGUrologia Clinica Bilbao
Bilbao, Spain
RECRUITINGDetection 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.
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