Micro-UltraSound In Cancer – Active Surveillance
Status
RECRUITING
Phase
NA
Age
≥ 18 Years
Enrollments
210Conditions
Prostate CancerSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Wayne Brisbane, MD
Principal Investigator
- Adam Kinnaird, MD, PhD
Eligibility Criteria
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
Study Plan
Combined MRI and micro-ultrasound guided prostate biopsy.
EXPERIMENTAL
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-ultrasoundDescription:
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.
Outcome Measures
Primary Outcome Measures
Cancer upgrading during Active surveillance by micro-ultrasound and MRI
Secondary Outcome Measures
Cancer upgrading during Active surveillance between imagine-guided versus systematic biopsy.
Timeline
Last Updated
July 29, 2025Start Date
September 28, 2022Today
December 15, 2025Completion Date ( Estimated )
June 30, 2033
Sponsors of this trial
Lead Sponsor
University of Alberta
RECRUITING 
18 - 80 Years