Abstract：
In this prospective observational study, we tested the feasibility and efficacy of a novel one-day PCa diagnosis path based on biparametric magnetic resonance (bpMRI) and digital pathology by fluorescence confocal microscopy (FCM). Patients aged 55-70 years scheduled for PBx due to increased PSA levels (3-10 ng/mL) and/or abnormal digitorectal examination were enrolled. All patients underwent bpMRI and PBx with immediate FCM evaluation of biopsy cores. Patients were asked to fill out a dedicated Patient Satisfaction Questionnaire. Patients\' satisfaction rates and concordance between digital pathology and standard HE evaluation were the outcomes of interest. Twelve patients completed our one-day PCa diagnosis path. BpMRI showed suspicious lesions in 7 patients. Digital pathology by FCM identified PCa in 5 (41.7%) of the 12 patients. Standard pathology confirmed the diagnosis made through digital pathology in all the cases. At a per patient level, high concordance between the methods was achieved in Gleason Grading (4 out of 5 patients). The level of agreement in the number of positive cores was lower but did not affect the choice of treatment in any of the 5 PCa cases. At a per core level, the agreement was very high for the diagnosis of anyPCa (96.2%) and csPCa (97.3%), with a k coefficient of 0.90 and 0.92, respectively (near perfect agreement). In conclusion, one-day PCa diagnosis by FCM represents a feasible, reliable, and fast diagnostic method that provides significant advantages in optimizing time and resources, leading to patients having a higher quality standard of care perception.
摘要：
在这项前瞻性观察研究中，我们通过荧光共聚焦显微镜（FCM）测试了基于双参数磁共振（bpMRI）和数字病理学的新型一日PCa诊断路径的可行性和有效性。纳入因PSA水平升高（3-10ng/mL）和/或指状直肠检查异常而计划进行PBx检查的55-70岁患者。所有患者均接受bpMRI和PBx，并立即FCM评估活检核心。要求患者填写专用的患者满意度问卷。患者的满意率以及数字病理学和标准HE评估之间的一致性是感兴趣的结果。12例患者完成了我们一天的PCa诊断路径。BpMRI显示7例可疑病灶。FCM的数字病理学在12例患者中有5例（41.7％）确定了PCa。在所有病例中，标准病理证实了通过数字病理做出的诊断。在每个患者的水平上，在Gleason分级(5例患者中有4例)中,两种方法的一致性很高.阳性核数量的一致性水平较低，但不影响5例PCa病例中任何一例的治疗选择。在每个核心级别，对于任何PCa（96.2％）和csPCa（97.3％）的诊断，该协议非常高，k系数分别为0.90和0.92(接近完美一致)。总之,FCM一天的PCa诊断代表了一种可行的，可靠,和快速诊断方法，在优化时间和资源方面提供显著优势，导致患者具有更高质量的护理感知标准。
