Micro-UltraSound In Cancer - Active Surveillance (MUSIC-AS)
University of Alberta
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
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Adult men with Gleason Grade Group 1 prostate cancer managed by active surveillance who require a confirmatory prostate biopsy Exclusion Criteria: * Men who cannot undergo a prostate MRI * Men who cannot undergo a prostate biopsy
Interventions
- DeviceHigh-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 UrologyLos Angeles, California
- Kipnes Urology Centre - Kaye Edmonton ClinicEdmonton, Alberta
- University of British ColumbiaVancouver, Alberta
- CIUSSS du Nord-de-L'Ile-De-MontrealMontreal, Quebec
- HumanitasMilan