Micro-Ultrasound for Detecting Clinically Significant Prostate Cancer in Active Surveillance (NCT07386171) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Micro-Ultrasound for Detecting Clinically Significant Prostate Cancer in Active Surveillance
Canada90 participantsStarted 2026-03-01
Plain-language 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.
Who can participate
Age range
45 Years – 75 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male participants aged 45 to 75 years
* Localized prostate cancer on active surveillance or newly diagnosed and eligible for active surveillance
* Negative multiparametric MRI (PI-RADS ≤2) or stable mpMRI findings on surveillance
* Prior prostate biopsy showing Grade Group 1, or Grade Group 2 (Gleason 3+4) with ≤10% pattern 4
* PSA ≤15 ng/mL
* PSA density \<0.15 ng/mL/cc
* Clinical stage ≤T2a
* Life expectancy \>10 years
* Ability to provide written informed consent and comply with study procedures
Exclusion Criteria:
* Prior definitive treatment for prostate cancer (e.g., radical prostatectomy, radiotherapy)
* Prior prostate surgery that may affect biopsy or imaging interpretation
* Contraindication to prostate biopsy
* Active urinary tract infection or prostatitis
* Inability to tolerate the biopsy procedure or follow study procedures
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity of Micro-Ultrasound for Clinically Significant Prostate Cancer (Grade Group ≥2)
Timeframe: At the time of the study biopsy procedure (baseline)
2
Specificity of Micro-Ultrasound for Clinically Significant Prostate Cancer (Grade Group ≥2)
Timeframe: At the time of the study biopsy procedure (baseline)
Trial details
NCT IDNCT07386171
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre