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Trial Title:
Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging.
NCT ID:
NCT06626022
Condition:
Prostate Cancer Screening
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
MRI
Description:
Standard prostate mpMRI.
Arm group label:
MRI
Intervention type:
Device
Intervention name:
ExactVu
Description:
microUltrasound
Arm group label:
microUltransound
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.
Criteria for 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.
Gender:
Male
Minimum age:
50 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of Alberta
Address:
City:
Edmonton
Zip:
T6G 1Z1
Country:
Canada
Contact:
Last name:
Adam Kinnaird, MD, PhD
Email:
ask@ualberta.ca
Start date:
December 1, 2024
Completion date:
November 30, 2029
Lead sponsor:
Agency:
University of Alberta
Agency class:
Other
Source:
University of Alberta
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06626022
