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

August 25, 2026 updated by: University of Alberta

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G1Z1
        • Kipnes Urology Centre - Kaye Edmonton Clinic
      • Vancouver, Alberta, Canada, V6T 1Z3
        • University of British Columbia
    • Quebec
      • Montreal, Quebec, Canada, H3L 1K5
        • CIUSSS du Nord-de-L'Ile-De-Montreal
  • Croatia
      • Zagreb, Croatia
        • University hospital centre Zagreb
  • Italy
      • Milan, Italy
        • Humanitas
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles, Department of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Immediately after biopsy.
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.
Time Frame: Immediately after 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

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2022

Primary Completion (Actual)

August 25, 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)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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