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ACTIVE NOT RECRUITING
NCT06935487
NA

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)

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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

DIAGNOSTIC_TEST

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