Back to Search Results- Not Yet Recruiting
- Screening
- Interventional
- Randomized
- Device
- PHASE3
- University of Alberta
- 50 - 70 Years
Study Purpose
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.
Intervention
Device : MRI
Device : ExactVu
Eligibility Requirements
Male sex;
Age 50-70;
PSA 3-20 and/or abnormal DRE;
Biopsy naïve.
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.
Recruiting status
Not Yet Recruiting
Estimated enrollment
1284
Study start date
Feb 15, 2025
Study end date
Nov 30, 2029
Last updated
Mar 24, 2025
Primary purpose
Screening
Design
Interventional
Intervention
Device
Study phase
PHASE3
Allocation
Randomized
Sponsor:
University of Alberta
Collaborator:
N/A
Investigator:
N/A
N/A
Publications
N/A
Websites
N/A
NCT06626022
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