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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Sensitivity of Micro-Ultrasound for Clinically Significant Prostate Cancer (Grade Group ≥2)
Study Overview
Brief 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.
Detailed Description
Study Rationale This is a prospective, single-arm, two-stage phase II diagnostic study designed to evaluate micro-ultrasound (mUS) as a supplemental imaging modality for the detection of clinically significant prostate cancer (csPCa) in men undergoing active surveillance (AS), or newly diagnosed men eligible for AS, with negative (PI-RADS ≤2) or stable multiparametric MRI (mpMRI) findings.
Active surveillance is widely adopted for men with low-risk and selected favorable intermediate-risk prostate cancer (PCa), aiming to defer or avoid definitive treatment while maintaining oncologic safety through structured monitoring.
mpMRI has become central to risk stratification, patient selection, and follow-up. However, clinically significant disease can be missed despite negative or stable mpMRI findings due to false-negative scans, inter-reader variability, limited access, and cost constraints. These limitations may lead to underdetection of csPCa and potential delays in appropriate treatment. In contrast to mpMRI, mUS can be performed at the point of care during the urology visit, enabling real-time lesion assessment and immediate targeted biopsy without the need to wait for radiology reporting, which may help mitigate MRI-related access delays and workflow bottlenecks.
mUS is a high-frequency ultrasound technology (29 MHz) providing real-time, high-resolution imaging of the prostate, enabling lesion characterization using the Prostate Risk Identification using Micro-Ultrasound (PRI-MUS) scoring system. mUS may detect suspicious features not identified on mpMRI and may therefore improve detection of csPCa, particularly in men with negative or stable mpMRI who are still undergoing biopsy due to clinical triggers or surveillance protocols.
Study Objectives The primary objective of this study is to determine the diagnostic performance of mUS for detecting csPCa in this population, using histopathology as the reference standard.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Micro-Ultrasound Imaging and Biopsy
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.
Intervention: Micro-Ultrasound (mUS) (Diagnostic Test)
Outcomes
Primary Outcomes
Sensitivity of Micro-Ultrasound for Clinically Significant Prostate Cancer (Grade Group ≥2)
Time Frame: At the time of the study biopsy procedure (baseline)
Sensitivity of micro-ultrasound for detecting clinically significant prostate cancer (csPCa), defined as Grade Group ≥2, using histopathology from targeted and systematic biopsy cores as the reference standard.
Specificity of Micro-Ultrasound for Clinically Significant Prostate Cancer (Grade Group ≥2)
Time Frame: At the time of the study biopsy procedure (baseline)
Specificity of micro-ultrasound for detecting clinically significant prostate cancer (csPCa), defined as Grade Group ≥2, using histopathology from targeted and systematic biopsy cores as the reference standard.
Secondary Outcomes
- Positive Predictive Value of Micro-Ultrasound for csPCa (Grade Group ≥2)(At the time of the study biopsy procedure (baseline))
- Negative Predictive Value of Micro-Ultrasound for csPCa (Grade Group ≥2)(At the time of the study biopsy procedure (baseline))
- Overall Diagnostic Accuracy of Micro-Ultrasound for csPCa (Grade Group ≥2)(At the time of the study biopsy procedure (baseline))
- Incremental Detection of csPCa Using Micro-Ultrasound Targeted Biopsy(At the time of the study biopsy procedure (baseline))
- Concordance Between Micro-Ultrasound Findings and mpMRI Findings(At the time of the study biopsy procedure (baseline))
Investigators
Rafael Sanchez-Salas
Associate Professor of Urology
McGill University Health Centre/Research Institute of the McGill University Health Centre