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Trial Title:
Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision
NCT ID:
NCT06281769
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
contrast enhanced ultrasound
CEUS
Multiparametric Ultrasound
Artificial intelligence
MRI
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
3D multi-parametric ultrasound targeted biopsy pathway using PcaVision
Description:
The procedure of 3D multiparametric ultrasound consists of 3 components: (1) intravenous
administration of ultrasound contrast; (2) rectal multi-parametric ultrasound imaging;
(3) PCaVision: artificial intelligence algorithm analyzing the images.
Arm group label:
Diagnostic evaluation of prostate cancer
Intervention type:
Diagnostic Test
Intervention name:
MRI targeted biopsy pathway
Description:
MRI sequences will include at least T1-weighted, T2-weighted, Diffusion-weighted imaging
(DWI) and calculation of apparent diffusion coefficient (ADC) maps. Scoring of suspicion
will be performed using the European Society of Urogenital Radiology (ESUR) PI-RADS
standardized scoring system. All lesions will be marked and delineated for MRI-TRUS
fusion 3D multiparametric ultrasound (mpUS).
Arm group label:
Diagnostic evaluation of prostate cancer
Summary:
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).
Detailed 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.
Criteria for eligibility:
Criteria:
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Amsterdam UMC - location VUmc
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Andros Clinics
Address:
City:
Baarn
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Spaarne Gasthuis
Address:
City:
Hoofddorp
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
St. Antonius
Address:
City:
Nieuwegein
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Fransiscus Gasthuis
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Recruiting
Start date:
February 26, 2024
Completion date:
January 1, 2025
Lead sponsor:
Agency:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Agency class:
Other
Collaborator:
Agency:
Angiogenesis Analytics
Agency class:
Other
Source:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06281769
https://doi.org/10.1016/j.euros.2022.12.018
