Micro-UltraSound In Cancer - Active Surveillance

Prostate Cancer Clinical Trial

— MUSIC-AS  

Official title:

Micro-UltraSound In Cancer - Active Surveillance (MUSIC-AS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05558241
• Other study ID #: HREBA.CC-22-0135
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2024
• Source: University of Alberta
• Contact: Adam Kinnaird, MD, PhD
• Phone: 780-407-5800
• Email: ask[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• High-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

Country	Name	City	State
Canada	Kipnes Urology Centre - Kaye Edmonton Clinic	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately after biopsy.
Secondary	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.	Immediately after biopsy.