Micro-UltraSound In Cancer - Active Surveillance

NCT ID: NCT05558241

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2033-06-30

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 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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective paired diagnostic trial
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

High-resolution micro-ultrasound

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam Kinnaird, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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University of California Los Angeles, Department of Urology

Los Angeles, California, United States

Site Status RECRUITING

Kipnes Urology Centre - Kaye Edmonton Clinic

Edmonton, Alberta, Canada

Site Status RECRUITING

University of British Columbia

Vancouver, Alberta, Canada

Site Status RECRUITING

CIUSSS du Nord-de-L'Ile-De-Montreal

Montreal, Quebec, Canada

Site Status RECRUITING

Humanitas

Milan, , Italy

Site Status RECRUITING

Countries

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United States Canada Italy

Central Contacts

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Adam Kinnaird, MD, PhD

Role: CONTACT

780-407-5800 ext. 321

Stacey Broomfield, PhD

Role: CONTACT

780-407-5800

Facility Contacts

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Adam Kinnaird, MD

Role: primary

780-407-5800

Nadia Lo Iacono

Role: primary

+39 0282247744

Nadia

Role: backup

Other Identifiers

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HREBA.CC-22-0135

Identifier Type: -

Identifier Source: org_study_id

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