Back to resultsMicro-UltraSound In Cancer - Active Surveillance (MUSIC-AS)
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High-resolution micro-ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Active surveillance, micro-ultrasound
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
Sites / Locations
- Kipnes Urology Centre - Kaye Edmonton ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Combined MRI and micro-ultrasound guided prostate biopsy.
Arm 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.
Outcomes
Primary Outcome Measures
Cancer upgrading during Active surveillance by micro-ultrasound and MRI
The primary outcome will be detection of ≥Grade Group 2 by each biopsy, technique in combination with the systematic biopsy.
Secondary Outcome Measures
Cancer upgrading during Active surveillance between imagine-guided versus systematic biopsy.
Secondary outcome will compare each imaged-guided biopsy technique to the standard-of-care 12 core systematic biopsy simultaneously obtained.
Full Information
NCT ID
NCT05558241
First Posted
September 23, 2022
Last Updated
January 12, 2023
Sponsor
University of Alberta
1. Study Identification
Unique Protocol Identification Number
NCT05558241
Brief Title
Micro-UltraSound In Cancer - Active Surveillance
Acronym
MUSIC-AS
Official Title
Micro-UltraSound In Cancer - Active Surveillance (MUSIC-AS)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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 determine if microUS is non-inferior 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Active surveillance, micro-ultrasound
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective paired diagnostic trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combined MRI and micro-ultrasound guided prostate biopsy.
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
High-resolution micro-ultrasound
Intervention 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.
Primary Outcome Measure Information:
Title
Cancer upgrading during Active surveillance by micro-ultrasound and MRI
Description
The primary outcome will be detection of ≥Grade Group 2 by each biopsy, technique in combination with the systematic biopsy.
Time Frame
Immediately after biopsy.
Secondary Outcome Measure Information:
Title
Cancer upgrading during Active surveillance between imagine-guided versus systematic biopsy.
Description
Secondary outcome will compare each imaged-guided biopsy technique to the standard-of-care 12 core systematic biopsy simultaneously obtained.
Time Frame
Immediately after biopsy.
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Kinnaird, MD, PhD
Phone
780-407-5800
Ext
321
Email
ask@ualberta.ca
Facility Information:
Facility Name
Kipnes Urology Centre - Kaye Edmonton Clinic
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G1Z1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Kinnaird, MD
Phone
780-407-5800
12. IPD Sharing Statement
Learn more about this trial
Micro-UltraSound In Cancer - Active Surveillance
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