Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging.
Recruiting · NCT06626022 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Alberta
View the official record on ClinicalTrials.gov →Interventions studied
ExactVuMRI
What this trial is about
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.
Who can take part
Age range
50 Years to 70 Years
Sex
Male
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male sex;
- Age 50-70;
- PSA 3-20 and/or abnormal DRE;
- Biopsy naïve.
Exclusion criteria
- Prior personal history of prostate cancer;
- Prior prostate imaging using microUS or MRI;
- Contraindication to microUS or MRI;
- Testosterone replacement therapy within last 12 months; or
- Androgen deprivation therapy within last 12 months.
Where it is running
9 locations listed across 2 US states.
- University of California, Los Angeles (UCLA) - Los Angeles, California, United States
- UT Southwestern Medical Center - Dallas, Texas, United States
- Urologia Clinica Bilbao - Bilbao, Spain
- CH de Martigues - Martigues, France
- Vestfold Hospital Trust - Tønsberg, Norway
- University of Alberta - Edmonton, Alberta, Canada
- University of British Columbia - Vancouver, British Columbia, Canada
- Sunnybrook Health Sciences Centre - Toronto, Ontario, Canada
- CIUSSS du Nord-de-l'Île-de-Montréal - Montréal, Quebec, Canada