NCT05558241

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
88mo left

Started Nov 2022

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
3 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Nov 2022Jul 2033

First Submitted

Initial submission to the registry

September 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 30, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
6.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2033

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3.8 years

First QC Date

September 23, 2022

Last Update Submit

April 7, 2026

Conditions

Prostate Cancer

Keywords

Active surveillancemicro-ultrasound

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Cancer upgrading during Active surveillance between imagine-guided versus systematic biopsy.

    Immediately after biopsy.

Study Arms (1)

Combined MRI and micro-ultrasound guided prostate biopsy.

EXPERIMENTAL

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

Interventions

High-resolution micro-ultrasoundDEVICE

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.

Combined MRI and micro-ultrasound guided prostate biopsy.

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult men with Gleason Grade Group 1 prostate cancer managed by active surveillance who require a confirmatory prostate biopsy

You may not qualify if:

  • Men who cannot undergo a prostate MRI
  • Men who cannot undergo a prostate biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of California Los Angeles, Department of Urology

Los Angeles, California, 90095, United States

RECRUITING

Kipnes Urology Centre - Kaye Edmonton Clinic

Edmonton, Alberta, T6G1Z1, Canada

RECRUITING

University of British Columbia

Vancouver, Alberta, V6T 1Z3, Canada

RECRUITING

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

Montreal, Quebec, H3L 1K5, Canada

RECRUITING

Humanitas

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Adam Kinnaird, MD, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Kinnaird, MD, PhD

CONTACT

780-407-5800ask@ualberta.ca

Stacey Broomfield, PhD

CONTACT

780-407-5800sbroomfi@ualberta.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Prospective paired diagnostic trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2022

First Posted

September 28, 2022

Study Start

November 30, 2022

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

July 30, 2033

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

IT(1)US(1)CA(3)