PCaVISTAPCaVision and MRI for Prostate Cancer Detection in Biopsy-Naïve and Active Surveillance Men
transrectal ultrasound of prostate (TRUS) with AI software algorithm
+ MRI prostate
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Diagnostic Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.806 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy 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
L'Institut Mutualiste Montsouris
Paris, FranceUniversity Klinikum Bonn
Bonn, GermanyMartini-Klinik am UKE
Hamburg, Germany