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NCT Number: NCT05558241

Micro-UltraSound In Cancer - Active Surveillance

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kipnes Urology Centre - Kaye Edmonton Clinic, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-resolution micro-ultrasound

Device

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Adam Kinnaird, MD, PhD

CONTACT

[email protected]

780-407-5800 ext. 321

Stacey Broomfield, PhD

CONTACT

[email protected]

780-407-5800

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Acronym: MUSIC-AS

Important dates

Study start
2022
Primary completion
2026
Study completion
2033
First posted
Sep 28, 2022
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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