Abstract
BackgroundThe diagnostic pathway for prostate cancer (PCa) is advancing towards an imaging-driven approach. Multiparametric magnetic resonance imaging, although increasingly used, has not shown sufficient accuracy to replace biopsy for now. The introduction of new ultrasound (US) modalities, such as quantitative contrast-enhanced US (CEUS) and shear wave elastography (SWE), shows promise but is not evidenced by sufficient high quality studies, especially for the combination of different US modalities. The primary objective of this study is to determine the individual and complementary diagnostic performance of greyscale US (GS), SWE, CEUS and their combination, multiparametric ultrasound (mpUS), for the detection and localization of PCa by comparison with corresponding histopathology.Methods/designIn this prospective clinical trial, US imaging consisting of GS, SWE and CEUS with quantitative mapping on 3 prostate imaging planes (base, mid and apex) will be performed in 50 patients with biopsy-proven PCa before planned radical prostatectomy using a clinical ultrasound scanner. All US imaging will be evaluated by US readers, scoring the four quadrants of each imaging plane for the likelihood of significant PCa based on a 1 to 5 Likert Scale. Following resection, PCa tumour foci will be identified, graded and attributed to the imaging-derived quadrants in each prostate plane for all prostatectomy specimens. Primary outcome measure will be the sensitivity, specificity, negative predictive value and positive predictive value of each US modality and mpUS to detect and localize significant PCa evaluated for different Likert Scale thresholds using receiver operating characteristics curve analyses.DiscussionIn the evaluation of new PCa imaging modalities, a structured comparison with gold standard radical prostatectomy specimens is essential as first step. This trial is the first to combine the most promising ultrasound modalities into mpUS. It complies with the IDEAL stage 2b recommendations and will be an important step towards the evaluation of mpUS as a possible option for accurate detection and localization of PCa.Trial registrationThe study protocol for multiparametric ultrasound was prospectively registered on Clinicaltrials.gov on 14 March 2017 with the registry name ‘Multiparametric Ultrasound-Study for the Detection of Prostate Cancer’ and trial registration number NCT03091231
Highlights
The diagnostic pathway for prostate cancer (PCa) is advancing towards an imaging-driven approach
In the evaluation of new PCa imaging modalities, a structured comparison with gold standard radical prostatectomy specimens is essential as first step
This trial is the first to combine the most promising ultrasound modalities into multiparametric ultrasound (mpUS). It complies with the IDEAL stage 2b recommendations and will be an important step towards the evaluation of mpUS as a possible option for accurate detection and localization of PCa
Summary
The diagnostic pathway for prostate cancer (PCa) is advancing towards an imaging-driven approach. Patients with a clinical suspicion of prostate cancer (PCa) based on elevated serum prostate specific antigen (PSA) and/or a suspicious digital rectal examination (DRE) should undergo a transrectal ultrasound (TRUS)-guided systematic biopsy as step in assessing presence of PCa [1]. This combination of tests results in a considerable rate of benign biopsy results, overdiagnosis of clinically insignificant PCa and underdiagnosis and undergrading of clinically significant PCa [2, 3]. Universal implementation of an mpMRI pathway seems unlikely for given the relatively high cost, low specificity with high rates of false positives, moderate inter-reader reproducibility and radiology training burden, limiting its broad use outside expert centres [7,8,9]
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