Micro-UltraSound In Cancer - Active Surveillance

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Alberta
Study ID
NCT05558241
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • High-resolution micro-ultrasound — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Nov 30, 2022
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Jul 30, 2033

Study Design

Enrollment
210 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Combined MRI and micro-ultrasound guided prostate biopsy.
    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 Measure

Cancer upgrading during Active surveillance by micro-ultrasound and MRI [ Time Frame: Immediately after biopsy. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Los Angeles, Department of UrologyLos AngelesCalifornia90095
Wayne Brisbane, MD (SUB_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California Los Angeles, Department of Urology· Los Angeles, CA

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