Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging.

NCT06626022 · tracked via the Priya Life Science Spain tracker

Sponsor

University of Alberta

Phase

Phase 3

Started

2025-05-08

Last updated

2026-09-25

Condition(s) studied

Prostate Cancer Screening

Investigational drug(s) / intervention(s)

MRIExactVu

MRI: Standard prostate mpMRI.

ExactVu: microUltrasound

Study 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.

Eligibility

Sex

MALE

Min age

50 Years

Max age

70 Years

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.

Primary outcome measure(s)

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.

Trial sites (9)

Facility	City	Region	Status
University of California, Los Angeles (UCLA)	Los Angeles	California	Recruiting
UT Southwestern Medical Center	Dallas	Texas	Not Yet Recruiting
University of Alberta	Edmonton	Alberta	Active Not Recruiting
University of British Columbia	Vancouver	British Columbia	Recruiting
Sunnybrook Health Sciences Centre	Toronto	Ontario	Recruiting
CIUSSS du Nord-de-l'Île-de-Montréal	Montréal	Quebec	Not Yet Recruiting
CH de Martigues	Martigues	France	Recruiting
Vestfold Hospital Trust	Tønsberg	Norway	Recruiting
Urologia Clinica Bilbao	Bilbao	Spain	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06626022 on ClinicalTrials.gov ↗ ← All trials in Spain