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Recruiting NCT05558241

Micro-UltraSound In Cancer - Active Surveillance

No phase Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-resolution micro-ultrasound.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, Croatia, Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 biops

Primary outcome measures

  • Cancer upgrading during Active surveillance by micro-ultrasound and MRI [Time frame: Immediately after biopsy.]
Secondary outcome measures (1)
  • Cancer upgrading during Active surveillance between imagine-guided versus systematic biopsy. [Time frame: Immediately after biopsy.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Canada · 3 centers
  • Kipnes Urology Centre - Kaye Edmonton Clinic — Edmonton
  • University of British Columbia — Vancouver
  • CIUSSS du Nord-de-L'Ile-De-Montreal — Montreal
United States · 1 center
  • University of California Los Angeles, Department of Urology — Los Angeles
Croatia · 1 center
  • University Hospital Centre Zagreb — Zagreb
Italy · 1 center
  • Humanitas — Milan

Identifiers

NCT: NCT05558241 · HREBA.CC-22-0135

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗