MUSIC-AS: Micro-UltraSound In Cancer - Active Surveillance

Sponsor

University of Alberta (Other)

Overall Status

Recruiting

CT.gov ID

NCT05558241

Collaborator

(none)

210

Enrollment

Location

Arm

41.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 determine if microUS is non-inferior 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Device: High-resolution micro-ultrasound	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

210 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective paired diagnostic trialProspective paired diagnostic trial

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
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.	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 biopsy will be counted as both microUS and MRI-guided. Finally, a standard 12-core systematic biopsy will be performed.

Arm

Intervention/Treatment

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.

Device: High-resolution micro-ultrasound

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kipnes Urology Centre - Kaye Edmonton Clinic	Edmonton	Alberta	Canada	T6G1Z1

Sponsors and Collaborators

University of Alberta

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Alberta

ClinicalTrials.gov Identifier:

NCT05558241

Other Study ID Numbers:

HREBA.CC-22-0135

First Posted:

Sep 28, 2022

Last Update Posted:

Jan 13, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by University of Alberta

Active surveillance

micro-ultrasound

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Jan 13, 2023