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RECRUITING
NCT05558241
NA

Micro-UltraSound In Cancer - Active Surveillance

Sponsor: University of Alberta

View on ClinicalTrials.gov

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.

Official title: Micro-UltraSound In Cancer - Active Surveillance (MUSIC-AS)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2022-11-30

Completion Date

2033-06-30

Last Updated

2025-07-29

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (5)

University of California Los Angeles, Department of Urology

Los Angeles, California, United States

Kipnes Urology Centre - Kaye Edmonton Clinic

Edmonton, Alberta, Canada

University of British Columbia

Vancouver, Alberta, Canada

CIUSSS du Nord-de-L'Ile-De-Montreal

Montreal, Quebec, Canada

Humanitas

Milan, Italy