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

Phase 3

Recruiting

• Conditions: Prostate Cancer Screening
• Interventions: Device: MRI; Device: ExactVu

• Registration Number: NCT06626022
• Lead Sponsor: University of Alberta

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-10-01
• Study First Posted: 2024-10-03
• Status Verified: 2025-05
• Study Start: 2025-05-08
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2029-11-30
• Study Completion: 2029-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 1284

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MRI	MRI	-
microUltransound	ExactVu	-

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (4)

University of California, Los Angeles (UCLA); 🇺🇸 Los Angeles, California, United States

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

CIUSSS du Nord-de-l'Île-de-Montréal; 🇨🇦 Montréal, Quebec, Canada