NCT06626022

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,284

participants targeted

Target at P75+ for phase_3

Timeline
44mo left

Started May 2025

Longer than P75 for phase_3

Geographic Reach
3 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
May 2025Nov 2029

First Submitted

Initial submission to the registry

October 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

May 8, 2025

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2029

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

4.6 years

First QC Date

October 1, 2024

Last Update Submit

March 11, 2026

Conditions

Prostate Cancer Screening

Outcome Measures

Primary Outcomes (1)

  • Detection of Clinically significant prostate cancer.

    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.

    Once enrolled, men will be followed for 1 year after the imaging test.

Study Arms (2)

MRI

ACTIVE COMPARATOR
Device: MRI

microUltransound

EXPERIMENTAL
Device: ExactVu

Interventions

MRIDEVICE

Standard prostate mpMRI.

MRI
ExactVuDEVICE

microUltrasound

microUltransound

Eligibility Criteria

Age50 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male sex;
  • Age 50-70;
  • PSA 3-20 and/or abnormal DRE;
  • Biopsy naïve.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of California, Los Angeles (UCLA)

Los Angeles, California, 90095, United States

NOT YET RECRUITING

University of Alberta

Edmonton, Alberta, T6G 1Z1, Canada

RECRUITING

University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

NOT YET RECRUITING

CIUSSS du Nord-de-l'Île-de-Montréal

Montréal, Quebec, H4J 1C5, Canada

NOT YET RECRUITING

Urologia Clinica Bilbao

Bilbao, Spain

RECRUITING

Central Study Contacts

Adam Kinnaird, MD, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 3, 2024

Study Start

May 8, 2025

Primary Completion (Estimated)

November 30, 2029

Study Completion (Estimated)

November 30, 2029

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)ES(1)US(1)