Micro-Ultrasound for Detecting Clinically Significant Prostate Cancer in Active Surveillance (NCT07386171)
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
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Jewish General Hospital — Montreal, Quebec
Age range: 45 Years to 75 Years
🧪 Interventions in This Study
- Micro-Ultrasound (mUS) (DIAGNOSTIC_TEST)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Jewish General Hospital — Montreal, Quebec
📞 Contact the Study Coordinator
Phone: (438) 828-5227
Email: rocio.roldan@mcgill.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.