Micro-UltraSound In Cancer - Active Surveillance

Study Overview
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Brief Summary
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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 determine if microUS is non-inferior 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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: High-resolution micro-ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective paired diagnostic trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined MRI and micro-ultrasound guided prostate biopsy.<br>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<br>* 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.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Active surveillance, micro-ultrasound