Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI prostate | Diagnostic Test | — | UNRESOLVED |
| transrectal ultrasound of prostate (TRUS) with AI software algorithm | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PCaVision Imaging + PCaVision-Targeted Biopsy
- description
- 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)
- interventionNames
- Diagnostic Test: transrectal ultrasound of prostate (TRUS) with AI software algorithm
- type
- ACTIVE_COMPARATOR
- label
- MRI Imaging + MRI-Targeted Biopsy
- description
- 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)
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.)
References
Publications (4)
- BACKGROUNDJager A, Vilanova JC, Michi M, Wijkstra H, Oddens JR. The challenge of prostate biopsy guidance in the era of mpMRI detected lesion: ultrasound-guided versus in-bore biopsy. Br J Radiol. 2022 Mar 1;95(1131):20210363. doi: 10.1259/bjr.20210363. Epub 2021 Jul 29. PMID 34324383
- BACKGROUNDvan Moorselaar RJ, Voest EE. Angiogenesis in prostate cancer: its role in disease progression and possible therapeutic approaches. Mol Cell Endocrinol. 2002 Nov 29;197(1-2):239-50. doi: 10.1016/s0303-7207(02)00262-9. PMID 12431818
- BACKGROUNDvan den Kroonenberg DL, Jager A, Garrido-Utrilla A, Reitsma JB, Postema AW, Beerlage HP, Oddens JR. Clinical Validation of Multiparametric Ultrasound for Detecting Clinically Significant Prostate Cancer Using Computer-Aided Diagnosis: A Direct Comparison with the Magnetic Resonance Imaging Pathway. Eur Urol Open Sci. 2024 Jul 1;66:60-66. doi: 10.1016/j.euros.2024.06.012. eCollection 2024 Aug. PMID 39050912
- BACKGROUNDJager A, Zwart MJ, Postema AW, van den Kroonenberg DL, Zwart W, Beerlage HP, Oddens JR, Mischi M. Development and validation of a framework for registration of whole-mount radical prostatectomy histopathology with three-dimensional transrectal ultrasound. BMC Urol. 2025 Apr 3;25(1):73. doi: 10.1186/s12894-025-01736-4. PMID 40175990