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.
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
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
Single group
Micro-Ultrasound (mUS)
Diagnostic testHigh-frequency micro-ultrasound prostate imaging with real-time lesion assessment. Targeted biopsy of suspicious lesions will be performed when present, along with concurrent systematic 12-core biopsy.
Sensitivity of Micro-Ultrasound for Clinically Significant Prostate Cancer (Grade Group ≥2)
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)
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.
Positive Predictive Value of Micro-Ultrasound for csPCa (Grade Group ≥2)
Positive predictive value of micro-ultrasound for detecting clinically significant prostate cancer, defined as Grade Group ≥2, using histopathology as the reference standard.
Negative Predictive Value of Micro-Ultrasound for csPCa (Grade Group ≥2)
Negative predictive value of micro-ultrasound for detecting clinically significant prostate cancer (csPCa), defined as Grade Group ≥2, using histopathology as the reference standard.
Overall Diagnostic Accuracy of Micro-Ultrasound for csPCa (Grade Group ≥2)
Overall diagnostic accuracy of micro-ultrasound for detecting clinically significant prostate cancer (csPCa), defined as Grade Group ≥2, using histopathology as the reference standard.
Incremental Detection of csPCa Using Micro-Ultrasound Targeted Biopsy
Number and proportion of clinically significant prostate cancers (Grade Group ≥2) detected on micro-ultrasound targeted biopsy cores, including csPCa cases that would not have been detected by systematic biopsy alone.
Biopsy-Related Adverse Events
Incidence and severity of biopsy-related adverse events and complications, graded using standardized criteria (e.g., Clavien-Dindo classification).
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