Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision

  • 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

info icon be male

info icon have an age of 18 years or older

info icon be biopsy naïve

info icon have a clinical suspicion of prostate cancer

info icon be scheduled for evaluation by prostate MRI based on a suspicious DRE and/or elevated serum PSA

info icon have signed informed consent

info icon active (urinary tract) infection or prostatitis

info icon a patient history with a cardiac right-to-left shunt.

info icon allergic to sulphur hexafluoride or any of the other ingredients of the ultrasound contrast agent SonoVue

info icon current treatment with dobutamine

info icon known severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg), uncontrolled systemic hypertension or respiratory distress syndrome

info icon any (further) contraindication to undergo MRI or 3D mpUS imaging

info icon incapable of understanding the language in which the patient information is given.

info icon medical history of prostate surgery

info icon 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

NCT06281769

Clinic Location Investigator Distance RECRUITING STATUS Contact