Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Completed

Conditions

Prostate Cancer

Treatments

Diagnostic Test: MRI targeted biopsy pathway

Diagnostic Test: 3D multi-parametric ultrasound targeted biopsy pathway using PcaVision

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06281769

NL82101.000.22

Details and patient eligibility

About

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).

Full description

All patients will undergo imaging using MRI and PCaVision during which suspicious lesions will be identified based on each imaging technique independently with readers being blinded for the results of the other imaging technique. Thereafter, a MRI targeted 3-core biopsy per lesion (maximum of 2 lesions) and/ or a PCaVision targeted 3-core biopsy (maximum of 2 lesions) will be performed by a one physician if suspicious lesions have been identified based on imaging. If lesions have been identified with both PCaVision and MRI in the same patient, the order of the targeted biopsies will be randomized. If the same lesion has been identified on both MRI and PCaVision, both a MRI-targeted and a PCaVision targeted biopsy will be separately performed. Histological examination of the targeted biopsies will be performed to determine presence of clinically significant prostate cancer.

Enrollment

467 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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