- Recruiting
- Diagnostic
- Interventional
- Diagnostic Test
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- 18 Years -
Study Purpose
The primary objective is to demonstrate non-inferiority of the detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI (MRI pathway).
Intervention
Diagnostic Test : 3D multi-parametric ultrasound targeted biopsy pathway using PcaVision
Diagnostic Test : MRI targeted biopsy pathway
Eligibility Requirements
be male
have an age of 18 years or older
be biopsy naïve
have a clinical suspicion of prostate cancer
be scheduled for evaluation by prostate MRI based on a suspicious DRE and/or elevated serum PSA
have signed informed consent
active (urinary tract) infection or prostatitis
a patient history with a cardiac right-to-left shunt.
allergic to sulphur hexafluoride or any of the other ingredients of the ultrasound contrast agent SonoVue
current treatment with dobutamine
known severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg), uncontrolled systemic hypertension or respiratory distress syndrome
any (further) contraindication to undergo MRI or 3D mpUS imaging
incapable of understanding the language in which the patient information is given.
medical history of prostate surgery
treatment of 5 alpha-reductase inhibitors for at least 3 months
Recruiting status
Recruiting
Estimated enrollment
438
Study start date
Feb 26, 2024
Study end date
Jan 01, 2025
Last updated
Mar 23, 2025
Primary purpose
Diagnostic
Design
Interventional
Intervention
Diagnostic Test
Study phase
NA
Allocation
Na
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator:
Angiogenesis Analytics
Investigator:
N/A
Publications
Websites
NCT06281769
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