Fluorescence confocal microscopy for margin assessment in prostatectomy: IP8-FLUORESCE study protocol

Radical prostatectomy (RP) represents the cornerstone of surgical treatment for prostate cancer. Assessing surgical margin status intraoperatively with current techniques remains challenging due to high costs in the context of an already stretched pathology workforce. Fluorescence confocal microscopy (FCM) is a promising technique to detect margins in prostate cancer surgery not bound by such limitations. The Imperial Prostate 8 - Fluorescence Confocal Microscopy for Rapid Evaluation of Surgical Cancer Excision (IP8-FLUORESCE) study is a multicentre, prospective, ex vivo, 'blinded', comparative cohort study. It aims to assess the accuracy of digital FCM for detection of prostate cancer at surgical margins compared to traditional histopathology. The primary endpoint is the accuracy of digital FCM for detection of prostate cancer at surgical margins on a per-patient level, reported with sensitivity, specificity, positive and negative predictive values. A total of 153 patients with localised prostate cancer undergoing robot-assisted RP across three UK National Health Service tertiary referral centres will be recruited. Following RP, prostate specimens will undergo immediate immersion in Acridine Orange solution, scanning 'en face' with FCM using the Histolog® Scanner, and subsequent formalin fixation and paraffin embedding. Two independent, 'blinded' uro-pathologists will report both the FCM images and the histopathology slides. Recruitment commenced on 17 August 2023.