Prostate Cancer
Conditions
Keywords
contrast enhanced ultrasound, CEUS, Multiparametric Ultrasound, Artificial intelligence, MRI
Brief 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.
Interventions
DIAGNOSTIC_TEST3D multi-parametric ultrasound targeted biopsy pathway using PcaVision
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.
DIAGNOSTIC_TESTMRI targeted biopsy pathway
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).
Sponsors
Angiogenesis Analytics
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Two weeks | csPCa defined as GG ≥ 2 in any of the biopsy cores taken from a lesion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of men in whom targeted biopsies could be safely omitted in the PCaVision pathway versus the MRI pathway. | Two weeks | 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. |
| 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). | Two weeks | (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 |
| 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. | 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. | Two weeks | — |
Countries
Netherlands
Outcome results
None listed