Prostate Cancer Screening
Conditions
Brief 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.
Interventions
DEVICEMRI
Standard prostate mpMRI.
DEVICEExactVu
microUltrasound
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Clinically significant prostate cancer. | Once enrolled, men will be followed for 1 year after the imaging test. | 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. |
Countries
Canada, France, Norway, Spain, United States
Contacts
CONTACTStacey Broomfield, PhD
PRINCIPAL_INVESTIGATORAdam Kinnaird, MD, PhD
University of Alberta
Outcome results
None listed