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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
467
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.
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).
Amsterdam UMC - location VUmc
Amsterdam, Netherlands
Andros Clinics
Baarn, Netherlands
Spaarne Gasthuis
Hoofddorp, Netherlands
St. Antonius
Nieuwegein, Netherlands
Fransiscus Gasthuis
Detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI.
csPCa defined as GG ≥ 2 in any of the biopsy cores taken from a lesion
Time frame: Two weeks
Proportion of men in whom targeted biopsies could be safely omitted in the PCaVision pathway versus the MRI pathway.
Defined as the number of men in whom no lesions for target biopsies have been identified by PCaVision while no CsPCa is detected in either MRI targeted biopsies or systematic biopsies.
Time frame: Two weeks
Detection rate of three different definitions of prostate cancer in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of targeted biopsies based on MRI (MRI pathway).
(i) ISUP ≥ 3 in any of the biopsy cores taken from a lesion; (ii) ISUP ≥ 2 with cribriform growth and/or intraductal carcinoma (CR/IDC) in any of the biopsy cores taken from a lesion; (iii) ISUP = 1
Time frame: Two weeks
Number of men in whom the PCaVision pathway generated insufficient quality images with the number of men with insufficient quality MRI images in the MRI pathway.
Time frame: Two weeks
Detection rate of clinically significant prostate cancer in targeted biopsies based on PCaVision imaging using various incremental levels of PCaVision's image quality requirements in comparison with the detection rate of targeted biopsies based on MRI.
Time frame: Two weeks
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Rotterdam, Netherlands