Clinical Validation of Transrectal Multiparametric Ultrasound Imaging Strategy (PCaVision) for the Detection of Clinically Significant Prostate Cancer: a Head-to-head Comparison With the MRI-based Strategy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 467
- Locations
- 5
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
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.
Time Frame: Two weeks
csPCa defined as GG ≥ 2 in any of the biopsy cores taken from a lesion
Secondary Outcomes
- Proportion of men in whom targeted biopsies could be safely omitted in the PCaVision pathway versus the MRI pathway.(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).(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)
- 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)
Investigators
Harrie P. Beerlage
Prof.dr. H.P. Beerlage
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)