NCT05558241 · University of Alberta
Micro-UltraSound In Cancer - Active Surveillance
(MUSIC-AS)
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations