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

University of Alberta

Status and phase: Enrolling; Phase 3

Conditions: Prostate Cancer Screening

Treatments: Device: MRI; Device: ExactVu

Study type: Interventional

Funder types: Other

Identifiers

NCT06626022

HREBA.CC-24-0325

Details and patient eligibility

About

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.

Enrollment: 1,284 estimated patients

Sex: Male

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,284 participants in 2 patient groups

MRI

Active Comparator group

Treatment:

Device: MRI

microUltransound

Experimental group

Treatment:

Device: ExactVu