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NCT Number: NCT06626022

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

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.

Recruiting

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Key information

Conditions

Prostate Cancer Screening

Age range

50 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

University of Alberta, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

MRI

Device

Standard prostate mpMRI.

ExactVu

Device

microUltrasound

Primary outcomes

  1. Detection of Clinically significant prostate cancer.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stacey Broomfield, PhD

CONTACT

[email protected]

+1-780-407-5800 ext. 321

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

A Phase 3, Multicenter, International, Non-inferiority, Randomized Clinical Trial Comparing Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging (MUSIC-Screen)

Acronym: MUSIC-Screen

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Oct 3, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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