Comparing micro-ultrasound and MRI for prostate cancer screening

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)

This study tests whether high-resolution micro-ultrasound works better than MRI for screening prostate cancer in men aged 50 to 70.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1284 (estimated)
• Ages: 50 Years to 70 Years
• Sex: Male
• Sponsor: University of Alberta (Academic / other)
• Locations: 6 sites (Los Angeles, California and 5 other locations)
• Trial ID: NCT06626022 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of high-resolution micro-ultrasound compared to multiparametric magnetic resonance imaging (MRI) for screening prostate cancer. Participants will be randomly assigned to receive either imaging modality to determine which is more effective in guiding decisions about prostate biopsies. The study focuses on men aged 50 to 70 with specific prostate health indicators, ensuring a targeted approach to screening. By comparing these two imaging techniques, the study seeks to improve prostate cancer detection methods.

Who should consider this trial

Good fit: Ideal candidates for this study are men aged 50 to 70 with a PSA level between 3 and 20 and/or abnormal digital rectal exam results who have never had a prostate biopsy.

Not a fit: Patients with a prior history of prostate cancer or those who have undergone prostate imaging using micro-ultrasound or MRI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate and less invasive screening methods for prostate cancer.

How similar studies have performed: Other studies have explored imaging modalities for prostate cancer, but this specific comparison of micro-ultrasound and MRI is relatively novel.

Eligibility criteria

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.

Where this trial is running

Los Angeles, California and 5 other locations

• University of California, Los Angeles (UCLA) — Los Angeles, California, United States (Not_yet_recruiting)
• University of Alberta — Edmonton, Alberta, Canada (Recruiting)
• University of British Columbia — Vancouver, British Columbia, Canada (Not_yet_recruiting)
• CIUSSS du Nord-de-l'Île-de-Montréal — Montréal, Quebec, Canada (Not_yet_recruiting)
• CH de Martigues — Martigues, France (Recruiting)
• Urologia Clinica Bilbao — Bilbao, Spain (Recruiting)

Study contacts

• Study coordinator: Adam Kinnaird, MD, PhD

Conditions Prostate Cancer Screening