NCT05558241

Micro-UltraSound In Cancer - Active Surveillance

Micro-UltraSound In Cancer - Active Surveillance (MUSIC-AS)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: University of Alberta · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the two imaging modalities (MRI and micro-ultrasound) during Active Surveillance of prostate cancer (PCa). Progression to clinically significant PCa will be assessed by first taking micro-US targeted samples (while blinded to MRI results), followed by MRI targeted samples, finishing with 12 systematic biopsy cores. The primary goal is to compare microUS to MRI for the detection of ≥GG2 PCa at confirmatory biopsy. This study will also collect blood samples from participants to be used for future biomarker studies.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	High-resolution micro-ultrasound	In a single biopsy session, first, a microUS-guided biopsy of regions of interest (ROIs) will be performed. The MRI fusion software will then be turned on, the clinician unblinded to the MRI results, and biopsy cores from within the boundaries of the MRI-fused lesion will be sampled from ROIs. Up to two ROIs identified on microUS or MRI will be targeted with up to 3 cores per ROI. If the MRI ROIs overlap with the microUS ROIs after unblinding, then the cores taken during the microUS-guided biopsy will be counted as both microUS and MRI-guided. Finally, a standard 12-core systematic biopsy will be performed.

Timeline

• Start date: 2022-11-30
• Primary completion: 2026-08-31
• Completion: 2033-07-30
• First posted: 2022-09-28
• Last updated: 2026-04-13

Locations

5 sites across 3 countries: United States, Canada, Italy