Status:
ACTIVE_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
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Angiogenesis Analytics
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Rationale The incidence of prostate cancer (PCa) has increased over the years. To diagnose PCa, histopathological confirmation is required. Different diagnostic pathways are currently available. Syste...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
- Current treatment with dobutamine
- Severe pulmonary hypertension (pulmonary artery pressure \> 90 mmHg), uncontrolled systemic hypertension, or respiratory distress syndrome
- Any other contraindication to MRI or 3D mpUS imaging
- Inability to understand the language of the patient information (i.e., language barrier)
- Previous treatment with focal therapy for prostate cancer (e.g., HIFU, cryotherapy, laser ablation, etc.)
Exclusion
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
806 Patients enrolled
Trial Details
Trial ID
NCT06935487
Start Date
April 1 2025
End Date
May 1 2027
Last Update
April 20 2025
Active Locations (10)
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1
Institut Paoli- Calmettes
Marseille, France
2
L'Institut Mutualiste Montsouris
Paris, France
3
University Klinikum Bonn
Bonn, Germany
4
Martini-Klinik am UKE
Hamburg, Germany