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NOT YET RECRUITING
NCT07386171
NA

Micro-Ultrasound for Detecting Clinically Significant Prostate Cancer in Active Surveillance

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

View on ClinicalTrials.gov

Summary

Active surveillance is a common approach for men with low-risk or favorable intermediate-risk prostate cancer, aimed at avoiding or delaying treatment while closely monitoring the disease. Multiparametric MRI (mpMRI) is widely used to guide diagnosis and follow-up, but it can miss clinically significant prostate cancer and may be limited by access, cost, and variability in interpretation. Micro-ultrasound is a high-resolution ultrasound technique that may improve real-time detection of suspicious prostate lesions using a standardized scoring system (PRI-MUS). The purpose of this study is to evaluate the diagnostic performance of micro-ultrasound for detecting clinically significant prostate cancer in men with negative or stable mpMRI findings, either at initial diagnosis or during active surveillance follow-up. Participants will undergo micro-ultrasound assessment of the prostate. Areas considered suspicious on micro-ultrasound may be targeted for biopsy, followed by systematic prostate sampling. Biopsy results will be used as the reference standard to determine whether clinically significant prostate cancer is present. The study will assess measures such as sensitivity, specificity, and predictive values of micro-ultrasound, as well as procedure-related complications.

Official title: Evaluating Micro-Ultrasound as a Supplemental Imaging Modality for Clinically Significant Prostate Cancer Detection in Men With Negative or Stable Multiparametric MRI on Active Surveillance or at Diagnosis

Key Details

Gender

MALE

Age Range

45 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-03-01

Completion Date

2027-06-01

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Micro-Ultrasound (mUS)

High-frequency micro-ultrasound prostate imaging with real-time lesion assessment. Targeted biopsy of suspicious lesions will be performed when present, along with concurrent systematic 12-core biopsy.

Locations (1)

Jewish General Hospital

Montreal, Quebec, Canada