Clinical Trial

European Multicenter Validation of PCaVision: A Head-to-Head Diagnostic Accuracy Study Comparing Multiparametric Transrectal Ultrasound to MRI for Clinically Significant Prostate Cancer Detection

Study acronym: PCaVISTA
Active, Not Recruiting
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Summary
The goal of this clinical trial is to learn if a new ultrasound-based imaging method (PCaVision) can accurately detect clinically significant prostate cancer in adult men (18 years and older) who are either undergoing initial evaluation or are already in active surveillance for prostate cancer. The main questions it aims to answer are: * Does PCaVision detect clinically significant prostate cancer as accurately as MRI? * Can some men safely avoid prostate biopsies based on PCaVision imaging results? Researchers will compare PCaVision-guided biopsies to MRI-guided biopsies to see if PCaVision performs as well as MRI in identifying aggressive prostate cancers. Participants will: * Undergo both an MRI and a PCaVision ultrasound scan * Receive targeted prostate biopsies based on any suspicious areas found in either scan * Possibly have follow-up visits to monitor for biopsy-related side effects
Trial Details
NCT Number NCT06935487
Lead Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: Angiogenesis Analytics
Conditions Prostate Cancer
Enrollment 806 participants
Start Date 2025-04-01
Primary Completion 2026-12 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2025-04-20