Recruiting
Phase 3

microUS vs. MRI

Sponsor:

University of Alberta

Code:

NCT06626022

Conditions

Prostate Cancer Screening

Eligibility Criteria

Sex: Male

Age: 50 - 70

Healthy Volunteers: Accepted

Interventions

MRI

ExactVu

Study Details

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.

Conditions

Prostate Cancer Screening

Study ID

NCT06626022

Start date

May 8, 2025

Status verified date

Sep, 2026

Completion date

Nov 30, 2029

Anticipated

Primary completion date

Nov 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 50 - 70

Healthy Volunteers: Accepted

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 Design

Enrollment

1284 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

active comparator: MRI

experimental: microUltransound

Interventions

MRI

Standard prostate mpMRI.

ExactVu

microUltrasound

Primary outcome measure

  • Detection of Clinically significant prostate cancer. [ Time Frame: Once enrolled, men will be followed for 1 year after the imaging test. ]

Central Contacts and Locations

Central contacts

Stacey Broomfield, PhD

+1-780-407-5800sbroomfi@ualberta.ca

Locations

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Miles Mannas, MD

mmannas@mail.ubc.ca

Principal Investigator:

Miles Mannas, MD

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Shania Nigli

416-480-6100shania.nigli@sunnybrook.ca

Principal Investigator:

Laurence Klotz, MD

More Information

Sponsor

University of Alberta

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-09-09.