University of Alberta
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.
Prostate Cancer
High-resolution micro-ultrasound
Not Applicable
| Study Type : | Interventional |
| Estimated Enrollment : | 210 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Diagnostic |
| Official Title : | Micro-UltraSound In Cancer - Active Surveillance (MUSIC-AS) |
| Actual Study Start Date : | January 1, 2023 |
| Estimated Primary Completion Date : | December 31, 2025 |
| Estimated Study Completion Date : | June 30, 2026 |
| Arm | Intervention/treatment |
|---|---|
|
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. |
Device: High-resolution micro-ultrasound |
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Kipnes Urology Centre - Kaye Edmonton Clinic
Edmonton, Alberta, Canada, T6G1Z1