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Fluorescence confocal microscopy for margin assessment in prostatectomy: IP8-FLUORESCE study protocol
Nikhil Mayor1,2, Alexander Light1,2, Anna Silvanto3
1Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK.
BJU International
|November 16, 2024
Summary
This study evaluates digital fluorescence confocal microscopy (FCM) for detecting prostate cancer at surgical margins after radical prostatectomy (RP). The goal is to improve accuracy and efficiency in margin assessment for better patient outcomes.
Area of Science:
- Uro-oncology
- Surgical pathology
- Medical imaging technology
Background:
- Radical prostatectomy (RP) is a primary treatment for prostate cancer, but assessing surgical margins intraoperatively is difficult.
- Current methods face challenges with cost and workforce limitations in pathology.
- Fluorescence confocal microscopy (FCM) offers a potential solution for real-time margin detection.
Purpose of the Study:
- To assess the diagnostic accuracy of digital FCM for detecting prostate cancer at surgical margins.
- To compare FCM's performance against traditional histopathology.
- To evaluate FCM's potential to improve intraoperative margin assessment in prostate cancer surgery.
Main Methods:
- The IP8-FLUORESCE study is a multicentre, prospective, ex vivo, blinded, comparative cohort study.
- 153 patients undergoing robot-assisted RP will be recruited across three UK centers.
- Prostate specimens will be scanned using digital FCM (Histolog® Scanner) after Acridine Orange immersion, followed by standard histopathology for comparison.
Main Results:
- The primary endpoint is the accuracy of digital FCM in detecting prostate cancer at surgical margins on a per-patient basis.
- Key metrics include sensitivity, specificity, positive predictive value, and negative predictive value.
- Results will be reported by two independent, blinded uro-pathologists.
Conclusions:
- Digital FCM shows promise as a tool for rapid and accurate assessment of surgical margins in prostate cancer.
- This technique could potentially overcome limitations of current intraoperative margin assessment methods.
- Further validation is ongoing to establish FCM's role in routine surgical practice.
