RecruitingNot ApplicableNCT05558241

Micro-UltraSound In Cancer - Active Surveillance

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

Sponsor

University of Alberta

Enrollment

210 participants

Start Date

Nov 30, 2022

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing micro-ultrasound (a high-resolution ultrasound) to standard MRI-guided biopsy in men with low-grade prostate cancer on active surveillance, to see which method better confirms whether the cancer remains low risk. **You may be eligible if:** - You are an adult man with Gleason Grade Group 1 prostate cancer (the lowest-risk form) - You are on active surveillance (monitoring rather than immediate treatment) - You need a confirmatory biopsy as part of your routine surveillance **You may NOT be eligible if:** - You cannot have a prostate MRI - You cannot undergo a prostate biopsy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHigh-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.