Clinical Validation of Multiparametric Ultrasound for Detecting Clinically Significant Prostate Cancer Using...

We present the protocol for a study testing the hypothesis that a computer-aided diagnosis (CAD) system for three-dimensional multiparametric ultrasound (3D mpUS) is noninferior to magnetic resonance imaging (MRI) in guiding prostate biopsies for detection of clinically significant prostate cancer (csPCa). The prospective study has a fully paired design for assessment of diagnostic accuracy and is registered on ClinicalTrials.gov as NCT06281769. A total of 438 biopsy-naïve men scheduled for prostate MRI evaluation because of an abnormal digital rectal examination and/or elevated serum prostate-specific antigen will be included. All patients will undergo both MRI (multiparametric or biparametric) and 3D mpUS with CAD (PCaVision). Suspicious lesions will be independently identified using each imaging technique. MRI targeted biopsy (TBx) and/or PCaVision TBx will be performed if suspicious lesions are identified on imaging. When both PCaVision and MRI identify lesions in an individual patient, the TBx order for this patient will be randomized. Three TBx samples per lesion will be taken for a maximum of two lesions per modality. The primary objective is the detection rate for csPCa (International Society of Urological Pathology grade group [GG] ≥2) with the PCaVision versus the MRI TBx pathway. The noninferiority margin for the absolute difference in detection rates is set at a difference of 5%. Secondary outcomes are the proportion of men in whom TBx could have been safely omitted in each pathway. Additional diagnostic accuracy analyses will be performed for different definitions of PCa (GG ≥3; GG ≥2 with cribriform growth and/or intraductal carcinoma; and GG 1). The frequency of insufficient image quality for the two pathways will also be assessed. Lastly, we will determine the diagnostic performance for csPCa detection at various 3D mpUS image quality thresholds for PCaVision.