Micro-UltraSound In Cancer - Active Surveillance

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Device: High-resolution micro-ultrasound

• Registration Number: NCT05558241
• Lead Sponsor: University of Alberta

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-28
• Study Start: 2023-01-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combined MRI and micro-ultrasound guided prostate biopsy.	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

Name	Time	Method
Cancer upgrading during Active surveillance by micro-ultrasound and MRI	Immediately after biopsy.	The primary outcome will be detection of ≥Grade Group 2 by each biopsy, technique in combination with the systematic biopsy.

Secondary Outcome Measures

Name	Time	Method
Cancer upgrading during Active surveillance between imagine-guided versus systematic biopsy.	Immediately after biopsy.	Secondary outcome will compare each imaged-guided biopsy technique to the standard-of-care 12 core systematic biopsy simultaneously obtained.

Trial Locations

Locations (4)

University of California Los Angeles, Department of Urology; 🇺🇸 Los Angeles, California, United States

University of British Columbia; 🇨🇦 Vancouver, Alberta, Canada

CIUSSS du Nord-de-L'Ile-De-Montreal; 🇨🇦 Montreal, Quebec, Canada

Kipnes Urology Centre - Kaye Edmonton Clinic; 🇨🇦 Edmonton, Alberta, Canada