Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging.
Status
RECRUITING
Phase
PHASE3
Age
50 - 70 Years
Enrollments
1284Conditions
Prostate Cancer ScreeningSummary
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.
Locations
0 locations Found with status Recruiting
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.
Study Plan
MRI
DEVICE:
MRIDescription:
Standard prostate mpMRI.
microUltransound
DEVICE:
ExactVuDescription:
microUltrasound
Outcome Measures
Primary Outcome Measures
Detection of Clinically significant prostate cancer.
Timeline
Last Updated
May 16, 2025Start Date
October 3, 2024Today
December 7, 2025Completion Date ( Estimated )
November 30, 2029
Sponsors of this trial
Lead Sponsor
University of Alberta
RECRUITING 
≥ 18 Years