Micro-ultrasound (microUS) represents a potential alternative to multiparametric magnetic resonance (mpMRI) in guiding prostate biopsy, with level 1 evidence demonstrating non-inferiority to detect Grade Group ≥2 (GG ≥ 2) prostate cancer in biopsy-naïve men. However, a critical gap remains in the screening pathway, in which imaging is needed to identify men at risk and determine whether biopsy is warranted.
MUSIC-Screen is a phase 3, open-label, noninferiority 1:1 randomized controlled trial evaluating microUS as an alternative imaging compared to mpMRI for determining the need for prostate biopsy in biopsy- and imaging- naïve men at risk for GG ≥ 2. A total of 1284 men will be randomized to undergo either microUS or mpMRI. Men with PRI-MUS 3-5 or PI-RADS 3-5 lesion will undergo targeted and systematic biopsy. Men with negative imaging and PSA density ≥ 0.15 will undergo systematic biopsy, while those with PSA density < 0.15 will defer biopsy.
The primary outcome is GG ≥ 2 detection in each study arm. The primary hypothesis is that microUS is non-inferior to mpMRI for screening and detection of GG ≥ 2. Secondary objectives include comparison of GG ≥ 2 detection rates in targeted cores among patients with PRI-MUS or PI-RADS scores of 3-5, proportion of men who defer biopsy but are diagnosed with GG ≥ 2 within 8 years, assessment of the negative predictive value of each imaging modality, and health economic analyses.
MUSIC-Screen will determine whether microUS can be used as an imaging modality to inform biopsy decision making that is non-inferior to mpMRI for GG ≥ 2 prostate cancer detection.
ClinicalTrials.gov Identifier: NCT06626022.
Contemporary clinical trials. 2026 Jul 20 [Epub ahead of print]
Melis Guer, Alp Tuna Beksac, Wayne Brisbane, Hannes Cash, Sangeet Ghai, Sunita Ghosh, Anna Heinrichs, Laurence Klotz, Hugo Lavigueur-Blouin, Sven Löffeler, Giovanni Lughezzani, Miles Mannas, Xiaosong Meng, Tara N Morgan, Bruno Nahar, Tiago Rodrigues, Julian P Struck, Raj Tiwari, Harry Toledano, Felipe Urdaneta, Adam Kinnaird
Division of Urology, Department of Surgery, University of Alberta, Edmonton, Canada; Department of Urology, University Hospital Tübingen, Germany. Electronic address: ., Department of Urology, Cleveland Clinic, Cleveland, OH, USA., Department of Urology, University of California Los Angeles (UCLA), Los Angeles, CA, USA., ProURO, Berlin, Germany; Department of Urology, University Clinic for Urology, Urooncology, Robot-assisted and Focal Therapy, University Clinic of Magdeburg, Germany., University Medical Imaging Toronto, Joint Department of Medical Imaging, University Health Network-Mount Sinai Hospital-Women's College Hospital, University of Toronto, Toronto General Hospital, Toronto, Canada., Department of Public Health Sciences, Henry Ford Health, Detroit, MI, USA; Department of Oncology, University of Alberta, Edmonton, Canada., Department of Urology, University Hospital Brandenburg an der Havel, BrandenburgMedical School and Faculty of Health Sciences Brandenburg, Brandenburg, Germany., Division of Urology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada., Department of Urology, Université de Montréal, Montréal, QC, Canada., Department of Urology, Vestfold Hospital Trust, Tønsberg, Norway., Department of Biomedical Sciences, Humanitas University, Milan, Italy; Department of Urology, IRCCS Humanitas Research Hospital, Milan, Italy., Vancouver Prostate Centre, Mohseni Institute of Urologic Sciences, Vancouver, British Columbia, Canada., Department of Urology, UT Southwestern Medical Center, Dallas, TX, USA., Department of Urology, Duke University School of Medicine, Durham, NC, USA., Department of Urology, University of Miami Miller School of Medicine, Miami, FL, USA., Department of Urology, Hospital Cruz Vermelha, Lisbon, Portugal., Department of Urology, Sengkang General Hospital, Singapore., Department of Urology, North Hospital, Aix-Marseille University, APHM, Marseille, France., Urología Clinica Bilbao, Bilbao, Spain., Division of Urology, Department of Surgery, University of Alberta, Edmonton, Canada; Department of Oncology, University of Alberta, Edmonton, Canada; Department of Radiology and Diagnostic Imaging, University of Alberta, Edmonton, Canada.