Suspended

PCaVISTAPCaVision and MRI for Prostate Cancer Detection in Biopsy-Naïve and Active Surveillance Men

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What is being tested

transrectal ultrasound of prostate (TRUS) with AI software algorithm

+ MRI prostate

Diagnostic Test
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: April 2025
See protocol details

Summary

Principal SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2025

Actual date on which the first participant was enrolled.

This study focuses on finding the best way to detect significant prostate cancer by comparing two different imaging methods: PCaVision and MRI. It targets men aged 18 and older who are either newly undergoing testing for prostate cancer or are already under active surveillance after previous tests. The goal is to see if the PCaVision method, which uses advanced ultrasound technology, is just as effective as the MRI method in identifying important cases of prostate cancer that need treatment. This could potentially make diagnosis more accessible and affordable, as MRI can be costly and less available. Participants will undergo both PCaVision ultrasound imaging and MRI scans. If either test finds suspicious areas, targeted biopsies will be performed to examine these areas more closely. Depending on the number of suspicious spots, up to 12 biopsies may be taken in one visit. The study will assess the ability of each imaging method to detect significant prostate cancer, aiming to prove that PCaVision is not less effective than MRI. While the study may involve some minor risks like infection or bleeding from the biopsies, these are considered low. The findings could lead to better diagnostic options for those at risk of prostate cancer, especially in places where MRI is not readily available.

Official TitleClinical 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
NCT06935487
Principal SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

806 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital Diseases

Criteria

Inclusion criteria: 1. male 2. 18 years of age or older 3. scheduled for evaluation by prostate MRI due to: * suspicious digital rectal examination (DRE) and/or * Elevated serum PSA levels, or as part of active surveillance (AS) follow-up 4. Have provided written informed consent Exclusion criteria: 1. Active urinary tract infection or prostatitis 2. A history of cardiac right-to-left shunt 3. Allergy to sulphur hexafluoride or any other ingredient in the ultrasound contrast agent SonoVue 4. Current treatment with dobutamine 5. Severe pulmonary hypertension (pulmonary artery pressure \> 90 mmHg), uncontrolled systemic hypertension, or respiratory distress syndrome 6. Any other contraindication to MRI or 3D mpUS imaging 7. Inability to understand the language of the patient information (i.e., language barrier) 8. Previous treatment with focal therapy for prostate cancer (e.g., HIFU, cryotherapy, laser ablation, etc.)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants undergo 3D multiparametric ultrasound (mpUS) imaging using PCaVision, a software-assisted diagnostic tool that combines B-mode, Shear Wave Elastography, and Contrast-Enhanced Ultrasound (CEUS). Suspicious lesions identified by PCaVision will be targeted for biopsy (up to 2 lesions, 3 cores each). * Transrectal 3D mpUS using PCaVision software (v1.1) * Injection of ultrasound contrast agent (SonoVue) * Targeted biopsy based on PCaVision lesion detection (up to 6 cores total)

Group II

Active Comparator
Participants undergo multiparametric MRI (mpMRI) of the prostate using 1.5T or 3T MRI systems. Suspicious lesions identified by MRI will be targeted for biopsy (up to 2 lesions, 3 cores each). * Prostate mpMRI with or without contrast * Image analysis following PI-RADS criteria * Targeted biopsy based on MRI lesion detection (up to 6 cores total)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 10 locations

Suspended

Institut Paoli- Calmettes

Marseille, FranceOpen Institut Paoli- Calmettes in Google Maps
Suspended

L'Institut Mutualiste Montsouris

Paris, France
Suspended

University Klinikum Bonn

Bonn, Germany
Suspended

Martini-Klinik am UKE

Hamburg, Germany
Suspended10 Study Centers