Micro-UltraSound In Cancer – Active Surveillance (MUSIC-AS): A Paired Prospective Non-Inferiority Trial Comparing Micro-Ultrasound And Multiparametric MRI For Detection Of Clinically Significant Prostate Cancer At Confirmatory Biopsy
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Background: Accurate risk assessment is essential for men on active surveillance (AS) of prostate cancer. Multiparametric MRI (mpMRI) improves detection of clinically significant prostate cancer (csPCa; Grade Group ? 2) but is limited by registration errors, contraindications (renal impairment, claustrophobia, ferromagnetic implants), and long wait times. Micro-ultrasound (microUS) is a high-resolution, real-time imaging modality that has been shown in randomized controlled trials to be non-inferior to mpMRI for csPCa detection in biopsy-naïve men. However, its diagnostic performance in men on AS remains unknown. Methods: MUSIC-AS is a multicenter, paired within-subject, prospective diagnostic trial comparing microUS and mpMRI for the detection of csPCa in men on AS. Eligible participants include men with previously diagnosed Grade Group 1 (GG1) prostate cancer requiring confirmatory biopsy. At biopsy, operators are initially blinded to MRI while obtaining microUS-guided cores from PRI-MUS 3–5 targets; MRI/US fusion is then activated to obtain MRI-guided cores from PI-RADS 3–5 targets, followed by a 12-core systematic biopsy. The primary endpoint is the detection of csPCa by each imaging-guided technique. The trial is powered for non-inferiority with a ?10% margin using a one-sided non-inferiority test of the difference between two correlated proportions. Results: 196 patients have been screened for the study at 6 centers in 4 countries. 163 have been enrolled in the study and 155 have undergone the interventions. Recruitment is continuing. Conclusions: MUSIC-AS will determine whether micro-ultrasound is non-inferior to mpMRI for detecting clinically significant prostate cancer in men on active surveillance. Confirmation of non-inferiority could support microUS as a cost-effective, time-efficient, and widely accessible imaging alternative in this population.
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