Abstract
BackgroundThe current standard for Prostate Cancer (PCa) detection in biopsy-naïve men consists of 10–12 systematic biopsies under ultrasound guidance. This approach leads to underdiagnosis and undergrading of significant PCa while insignificant PCa may be overdiagnosed. The recent developments in MRI and Contrast Enhanced Ultrasound (CEUS) imaging have sparked an increasing interest in PCa imaging with the ultimate goal of replacing these “blind” systematic biopsies with reliable imaging-based targeted biopsies.Methods/designIn this trial, we evaluate and compare the PCa detection rates of multiparametric (mp)MRI-targeted biopsies, CEUS-targeted biopsies and systematic biopsies under ultrasound guidance in the same patients. After informed consent, 299 biopsy-naïve men will undergo mpMRI scanning and CEUS imaging 1 week prior to the prostate biopsy procedure. During the biopsy procedure, a systematic transrectal 12-core biopsy will be performed by one operator blinded for the imaging results and targeted biopsy procedure. Subsequently a maximum of 4 CEUS-targeted biopsies and/or 4 mpMRI-targeted biopsies of predefined locations determined by an expert CEUS reader using quantification techniques and an expert radiologist, respectively, will be taken by a second operator using an MRI-US fusion device. The primary outcome is the detection rate of PCa (all grades) and clinically significant PCa (defined as Gleason score ≥7) compared between the three biopsy protocols.DiscussionThis trial compares the detection rate of (clinically significant) PCa, between both traditional systematic biopsies and targeted biopsies based on predefined regions of interest identified by two promising imaging technologies. It follows published recommendations on study design for the evaluation of imaging guided prostate biopsy techniques, minimizing bias and allowing data pooling. It is the first trial to combine mpMRI imaging and advanced CEUS imaging with quantification.Trial registrationThe Dutch Central Committee on Research Involving Human Subjects registration number NL52851.018.15, registered on 3 Nov 2015. Clinicaltrials.gov database registration number NCT02831920, retrospectively registered on 5 July 2016.
Highlights
The current standard for Prostate Cancer (PCa) detection in biopsy-naïve men consists of 10–12 systematic biopsies under ultrasound guidance
This trial compares the detection rate of PCa, between both traditional systematic biopsies and targeted biopsies based on predefined regions of interest identified by two promising imaging technologies
It is the first trial to combine mpMRI imaging and advanced Contrast Enhanced Ultrasound (CEUS) imaging with quantification
Summary
Improvement of the PCa diagnostic pathway is necessary, and will likely depend on the advances in PCa imaging. Contrast -enhanced ultrasound has shown promising results, but should currently be viewed as experimental This trial will provide data on both these techniques, allowing comparison and assessment of complementarity. In our study design all patients undergo both imaging procedures and both targeted and systematic biopsies. To prevent potential bias by post-biopsy haemorrhage seen on ultrasound the targeted biopsies are performed after the systematic biopsies This way we prevent information gathered from one imaging technique to influence biopsy targeting for the other imaging technique. We believe that our trial will provide important and necessary data on one of the most relevant topics in PCa care This data is gathered in a recommended, standardized fashion to minimize bias and allow data pooling. Abbreviations (mp)MRI: (multiparametric) Magnetic Resonance Imaging; AUC: Area Under the Curve; CDR: Cancer Detection Rate; CEUS: Contrast - Enhanced Ultrasound; CUDI: Contrast Ultrasound Dispersion Imaging; DRE: Digital Rectal Examination; EAU: European Association of Urology; IDM: Interdepartmental Monitoring; IRB: Institutional Review Board; PCa: Prostate Cancer; PSA: Prostate Specific Antigen; TIC: Time-IntensityCurve; TRUS: Transrectal Ultrasound; UCA: Ultrasound Contrast Agent
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