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Clinical Trials in France / NCT06935487
Active, not recruiting Not applicable

European Multicenter Validation of PCaVision: A Head-to-Head Diagnostic Accuracy Study Comparing Multiparametric Transrectal Ultrasound to MRI for Clinically Significant Prostate Cancer Detection

NCT06935487 · tracked via the Priya Life Science France tracker
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Phase
Not applicable
Started
2025-04-01
Last updated
2025-04-20

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

transrectal ultrasound of prostate (TRUS) with AI software algorithmMRI prostate

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

MRI prostate: MRI for detection of lesions suspected for prostate cancer

Study 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

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.)

Primary outcome measure(s)

  • Number of Participants With Clinically Significant Prostate Cancer (csPCa) Detected by PCaVision-Targeted Biopsies Compared to MRI-Targeted Biopsies — 12 months
    Clinically significant prostate cancer (csPCa) is defined as ISUP Grade Group (GG) ≥ 2. The number of participants in whom csPCa is detected through PCaVision-targeted biopsies will be compared to the number of participants with csPCa detected through MRI-targeted biopsies. The comparison will be performed separately for two patient cohorts: 1. Biopsy-naïve or prior negative biopsy patients 2. Patients under active surveillance (AS) A non-inferiority margin of 5 percentage points will be used.

Trial sites (10)

FacilityCityRegionStatus
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

Other trials for the same condition

Clinical and Dosimetric Study of Patients Treated With 177Lu-PSMA-617 for Prostate Cancer. Recruiting
European Registry of Next Generation Imaging in Advanced Prostate Cancer Recruiting
Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer Recruiting
Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC Active, not recruiting
Prostate Cancer Early Detection Using Serial MRI Examinations Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06935487 on ClinicalTrials.gov ↗ ← All trials in France