NCT07386171Not yet recruiting
Micro-Ultrasound for Detecting Clinically Significant Prostate Cancer in Active Surveillance
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
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 27 Jan 2026
- Start date
- 1 Mar 2026
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Diseases
- Prostate cancer
- NCT number
- NCT07386171
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 1 Mar 2026 to the primary completion date, 1 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior definitive treatment for prostate cancer (e.g., radical prostatectomy, radiotherapy)
- Prior prostate surgery that may affect biopsy or imaging interpretation
Other illness
- Active urinary tract infection or prostatitis
Other
- Contraindication to prostate biopsy
- Inability to tolerate the biopsy procedure or follow study procedures
Who the study is looking for
- 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
Age in the registry: 45 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.