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European Multicenter Validation of PCaVision: A Head-to-Head Diagnostic Accuracy Study Comparing Multiparametric Transrectal Ultrasound to MRI for Clinically Significant Prostate Cancer Detection
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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
Official title: Clinical Validation of Transrectal Multiparametric Ultrasound (PCaVision) for Detecting Clinically Significant Prostate Cancer: A European Head-to-Head Comparison With MRI in Primary Diagnosis and Active Surveillance Populations
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
806
Start Date
2025-04-01
Completion Date
2027-05
Last Updated
2025-04-20
Healthy Volunteers
No
Conditions
Interventions
transrectal ultrasound of prostate (TRUS) with AI software algorithm
Transrectal ultrasound of prostate (TRUS) with AI software algorithm for detection of lesions suspected for prostate cancer
MRI prostate
MRI for detection of lesions suspected for prostate cancer
Locations (10)
Institut Paoli- Calmettes
Marseille, France
L'Institut Mutualiste Montsouris
Paris, France
University Klinikum Bonn
Bonn, Germany
Martini-Klinik am UKE
Hamburg, Germany
Urologische Klinik München- Planegg
Planegg, Germany
Università degli Studi di Foggia
Foggia, Italy
University of Padua
Padova, Italy
Amsterdam UMC
Amsterdam, Netherlands
Oslo University hospital Ullevål
Oslo, Norway
Fundació Puigvert
Barcelona, Spain