Micro-Ultrasound for Prostate Cancer

(MUS-AS Trial)

Overseen By Claudia Covarrubias, MD

Age: 18+

Sex: Male

Trial Phase: Academic

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

Disqualifiers: Prior prostate treatment, Prostate surgery, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Maurice Anidjar, MD, PhD

Principal Investigator

Jewish General Hospital

Rafael Sanchez-Salas, MD

Principal Investigator

McGill Universiy Health Center // Jewish General Hospital

Rocio Roldan-Testillano, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

Men aged 45-75 with low-risk prostate cancer who are on active surveillance or newly diagnosed and eligible for it. They must have a life expectancy over 10 years, PSA levels ≤15 ng/mL, and negative or stable MRI results. Men with more advanced cancer stages or higher PSA density are not eligible.

Inclusion Criteria

I can sign and follow the study's requirements.

My MRI results for cancer are negative or unchanged.

I am a man aged between 45 and 75.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Micro-Ultrasound Assessment and Biopsy

Participants undergo micro-ultrasound assessment of the prostate. Suspicious lesions are targeted for biopsy, followed by systematic prostate sampling.

At the time of the study biopsy procedure (baseline)

1 visit (in-person)

Follow-up

Participants are monitored for biopsy-related adverse events and complications.

Up to 30 days post-biopsy

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Micro-Ultrasound

Trial Overview

The trial is testing micro-ultrasound's ability to detect significant prostate cancer in men whose MRIs don't show worsening signs of the disease. It involves scanning the prostate with this new technique and possibly taking biopsies from suspicious areas.

How Is the Trial Designed?

Group I: Micro-Ultrasound Imaging and Biopsy Experimental Treatment 1 Intervention

All participants will undergo micro-ultrasound prostate assessment. If a suspicious lesion is identified, targeted biopsy will be performed. All participants will also undergo a 12-core systematic biopsy during the same session.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

476

Recruited

170,000+