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

NCT ID: NCT06626022

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-08

Study Completion Date

2029-11-30

Brief Summary

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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

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Conditions

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Prostate Cancer Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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MRI

Group Type ACTIVE_COMPARATOR

MRI

Intervention Type DEVICE

Standard prostate mpMRI.

microUltransound

Group Type EXPERIMENTAL

ExactVu

Intervention Type DEVICE

microUltrasound

Interventions

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MRI

Standard prostate mpMRI.

Intervention Type DEVICE

ExactVu

microUltrasound

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California, Los Angeles (UCLA)

Los Angeles, California, United States

Site Status NOT_YET_RECRUITING

University of Alberta

Edmonton, Alberta, Canada

Site Status RECRUITING

University of British Columbia

Vancouver, British Columbia, Canada

Site Status NOT_YET_RECRUITING

CIUSSS du Nord-de-l'Île-de-Montréal

Montréal, Quebec, Canada

Site Status NOT_YET_RECRUITING

Countries

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United States Canada

Central Contacts

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Adam Kinnaird, MD, PhD

Role: CONTACT

+1-780-407-5800 ext. 321

Facility Contacts

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Wayne Brisbane, MD

Role: primary

Adam Kinnaird, MD, PhD

Role: primary

Miles Mannas, MD

Role: primary

Hugo Lavigueur-Blouin, MD

Role: primary

Other Identifiers

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HREBA.CC-24-0325

Identifier Type: -

Identifier Source: org_study_id

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