Micro-UltraSound In Cancer - Active Surveillance

ClinicalTrials.gov ID

NCT05558241

Lead Sponsor

University of AlbertaOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

210Estimated

Last Update Posted

Jun 25, 2026Actual

Start Date

Nov 30, 2022Actual

Primary Completion Date

Aug 31, 2026Estimated

Completion Date

Jul 30, 2033Estimated

Official Title

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

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.

• Prostate Cancer

• High-resolution micro-ultrasound

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Male

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Diagnostic

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

University of AlbertaOTHER

nadia.lo_iacono@cancercenter.humanitas.it+39 0282247744

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