Micro-UltraSound In Cancer - Active Surveillance (MUSIC-AS)
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• Adult men with Gleason Grade Group 1 prostate cancer managed by active surveillance who require a confirmatory prostate biopsy
Locations
United States
California
University of California Los Angeles, Department of Urology
RECRUITING
Los Angeles
Other Locations
Canada
Kipnes Urology Centre - Kaye Edmonton Clinic
RECRUITING
Edmonton
CIUSSS du Nord-de-L'Ile-De-Montreal
RECRUITING
Montreal
University of British Columbia
RECRUITING
Vancouver
Italy
Humanitas
RECRUITING
Milan
Contact Information
Primary
Adam Kinnaird, MD, PhD
ask@ualberta.ca
780-407-5800
Backup
Stacey Broomfield, PhD
sbroomfi@ualberta.ca
780-407-5800
Time Frame
Start Date: 2022-11-30
Estimated Completion Date: 2033-06-30
Participants
Target number of participants: 210
Treatments
Experimental: Combined MRI and micro-ultrasound guided prostate biopsy.
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.
Related Therapeutic Areas
Sponsors
Leads: University of Alberta