NCT06935487Active, not recruiting
European Multicenter Validation of PCaVision: A Head-to-Head Diagnostic Accuracy Study Comparing Multiparametric Transrectal Ultrasound to MRI for Clinically Significant Prostate Cancer Detection
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
Source: ClinicalTrials.gov · Last updated 20 Apr 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 806 (estimated)
- First submitted
- 4 Apr 2025
- Start date
- 1 Apr 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Diseases
- Prostate cancer
- NCT number
- NCT06935487
What you commit to
- Study type: Interventional
- Planned participants: 806
- From 1 Apr 2025 to the primary completion date, Dec 2026
- 10 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with dobutamine
- Previous treatment with focal therapy for prostate cancer (e.g., HIFU, cryotherapy, laser ablation, etc.)
Other illness
- Active urinary tract infection or prostatitis
- A history of cardiac right-to-left shunt
- Allergy to sulphur hexafluoride or any other ingredient in the ultrasound contrast agent SonoVue
- Severe pulmonary hypertension (pulmonary artery pressure \> 90 mmHg), uncontrolled systemic hypertension, or respiratory distress syndrome
Other
- Any other contraindication to MRI or 3D mpUS imaging
- Inability to understand the language of the patient information (i.e., language barrier)
Who the study is looking for
- male
- 18 years of age or older
- 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
- Have provided written informed consent
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Klinikum Bonn Coordinator of this site? Confirm its status | Bonn | Germany | Unknown status |
| Martini-Klinik am UKE Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Urologische Klinik München- Planegg Coordinator of this site? Confirm its status | Planegg | Germany | Unknown status |
| Fundació Puigvert Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| L Institut Mutualiste Montsouris Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Università degli Studi di Foggia Coordinator of this site? Confirm its status | Foggia | Italy | Unknown status |
| University Of Padua Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Oslo University Hospital Ullevål Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.