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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: High-resolution micro-ultrasound

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam Kinnaird, MD, PhD; Phone Number: 321 780-407-5800; Email: ask@ualberta.ca
• Study Contact Backup: Name: Stacey Broomfield, PhD; Phone Number: 780-407-5800; Email: sbroomfi@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G1Z1
      • Recruiting
      • Kipnes Urology Centre - Kaye Edmonton Clinic
      • Contact: Adam Kinnaird, MD; Phone Number: 780-407-5800
      • Principal Investigator: Adam Kinnaird, MD, PhD
    • Vancouver, Alberta, Canada, V6T 1Z3
      • Recruiting
      • University of British Columbia
      • Sub-Investigator: Miles Mannas, MD
  • Quebec
    • Montreal, Quebec, Canada, H3L 1K5
      • Recruiting
      • CIUSSS du Nord-de-l'Île-de-Montréal
      • Sub-Investigator: Hugo Lavigueur-Blouin, MD
• Italy
  • Milan, Italy
    • Recruiting
    • Humanitas
    • Contact: Nadia Lo Iacono; Phone Number: +39 0282247744; Email: nadia.lo_iacono@cancercenter.humanitas.it
    • Contact: Nadia
    • Principal Investigator: Giovanni Lughezzani, MD, MD
• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California Los Angeles, Department of Urology
      • Sub-Investigator: Wayne Brisbane, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Adam Kinnaird, MD, PhD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): July 30, 2033

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Active surveillance; micro-ultrasound
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: HREBA.CC-22-0135

Drug and device information, study documents

• 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