Micro-Ultrasound for Prostate Cancer

(MUS-AS Trial)

RR
CC
Overseen ByClaudia Covarrubias, MD
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new technique called micro-ultrasound to detect prostate cancer that traditional scans might miss. The goal is to determine if this method can better identify significant prostate cancer in men who are either newly diagnosed or under active surveillance. Participants will receive a scan and possibly a targeted biopsy if anything appears suspicious. It is suitable for men with low-risk prostate cancer who have stable or negative results from previous MRI scans. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance prostate cancer detection.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that micro-ultrasound is safe for prostate cancer detection?

Research has shown that micro-ultrasound is generally safe and effective for detecting prostate cancer. Studies have found it works as well as MRI in identifying significant prostate issues, without introducing major safety concerns.

In one study, many men used micro-ultrasound to detect prostate cancer, and no unusual safety issues were reported. As a high-resolution imaging technique, it provides clear pictures of the prostate, helping doctors identify areas that might need further examination. The study also checked for complications related to the procedure and found no significant problems.

Overall, while micro-ultrasound is a newer method, current evidence suggests it is safe for detecting prostate cancer.1234

Why are researchers excited about this trial?

Researchers are excited about micro-ultrasound for prostate cancer because it offers a more detailed and precise imaging technique compared to traditional methods like MRI or standard ultrasound. Unlike these existing options, micro-ultrasound can detect smaller lesions at an earlier stage, potentially leading to earlier and more targeted biopsies. This could improve the accuracy of prostate cancer diagnoses and reduce the need for multiple invasive procedures.

What evidence suggests that micro-ultrasound is effective for detecting prostate cancer?

Research has shown that micro-ultrasound, which all participants in this trial will undergo, effectively detects prostate cancer. In one study, it correctly identified cancer in 92.5% of cases. Another study found that 42% of the cancers detected were serious and required treatment. Micro-ultrasound uses a special system called PRI-MUS to identify suspicious areas, aiding in the accurate detection of significant prostate issues. This method may surpass the usual PSA tests in identifying serious cases.1345

Who Is on the Research Team?

MA

Maurice Anidjar, MD, PhD

Principal Investigator

Jewish General Hospital

RR

Rocio Roldan-Testillano, MD

Principal Investigator

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

RS

Rafael Sanchez-Salas, MD

Principal Investigator

McGill Universiy Health Center // Jewish General Hospital

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.
See 6 more

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?

1

Treatment groups

Experimental Treatment

Group I: Micro-Ultrasound Imaging and BiopsyExperimental Treatment1 Intervention

Find a Clinic Near You

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+

Citations

The value of micro-ultrasound for prostate cancer screening

This retrospective analysis was designed as a real-world data study derived from routine outpatient early prostate cancer screening. The ...

AI‐enhanced micro‐ultrasound improves detection of clinically ...

At a fixed threshold, sensitivity was 92.5% and specificity 68.1%, outperforming a clinical model based on prostate‐specific antigen (PSA), ...

Detection of Clinically Significant Prostate Cancer Using ...

MB achieved higher Cs PCa detection in systematic and combined biopsies, while targeted cores alone showed no significant difference.

Microultrasound-targeted biopsies in patients with ...

Prostate cancer was detected in 124 patients (62.1%), with csPCa confirmed in 84 cases (42%). Lesions with PRI-MUS ≥4 were significantly ...

Evaluation of prostate cancer detection using micro- ...

Micro-ultrasound was found to have equivalent performance to retrospective MRI review for index lesion detection (91.7% vs. 80%), while ...