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Trial Title:
Micro-UltraSound In Cancer - Active Surveillance
NCT ID:
NCT05558241
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Active surveillance
micro-ultrasound
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Prospective paired diagnostic trial
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
High-resolution micro-ultrasound
Description:
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.
Arm group label:
Combined MRI and micro-ultrasound guided prostate biopsy.
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.
Criteria for 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
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Kipnes Urology Centre - Kaye Edmonton Clinic
Address:
City:
Edmonton
Zip:
T6G1Z1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Adam Kinnaird, MD
Phone:
780-407-5800
Start date:
January 1, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
University of Alberta
Agency class:
Other
Source:
University of Alberta
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05558241
