RESUMEN
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.
RESUMEN
Background and objective: A combined approach of magnetic resonance imaging (MRI)-targeted biopsy (TBx) and bilateral systematic biopsy (SBx) is advised in patients who have an increased risk of prostate cancer (PCa). The diagnostic gain of SBx in detecting PCa for treatment planning of patients undergoing robot-assisted radical prostatectomy (RARP) is unknown. This study aims to determine the impact of omitting contralateral SBx on the surgical planning of patients undergoing RARP in terms of nerve-sparing surgery (NSS) and extended pelvic lymph node dissection (ePLND). Methods: Case files from 80 men with biopsy-proven PCa were studied. All men had a unilateral suspicious lesion on MRI, and underwent TBx and bilateral SBx. Case files were presented to five urologists for the surgical planning of RARP. Each case file was presented randomly using two different sets of information: (1) results of TBx + bilateral SBx, and (2) results of TBx + ipsilateral SBx. The urologists assessed whether they would perform NSS and/or ePLND. Key findings and limitations: A change in the surgical plan concerning NSS on the contralateral side was observed in 9.0% (95% confidence interval [CI] 6.4-12.2) of cases. Additionally, the indication for ePLND changed in 5.3% (95% CI 3.3-7.9) of cases. Interobserver agreement based on Fleiss' kappa changed from 0.44 to 0.15 for the indication of NSS and from 0.84 to 0.83 for the indication of ePLND. Conclusions and clinical implications: In our series, the diagnostic information obtained from contralateral SBx has limited impact on the surgical planning of patients with a unilateral suspicious lesion on MRI scheduled to undergo RARP. Patient summary: In patients with one-sided prostate cancer on magnetic resonance imaging, omitting biopsies on the other side rarely changed the surgical plan with respect to nerve-sparing surgery and the indication to perform extended lymph node dissection.