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Real-time Fluorescence Microscopy for Intraoperative Assessment of Prostate Biopsy Cores (FLASH)
Sponsor: Shanghai East Hospital
Summary
Current prostate cancer diagnosis relies on MRI-targeted biopsy combined with a 12-core systematic biopsy. The systematic component is a major driver of overdiagnosis of insignificant cancer and biopsy-related morbidity, and conventional pathology takes 1-2 weeks, causing significant patient anxiety. The EndoScell system is a handheld, real-time fluorescence microscope that can display the microscopic structure of a fresh biopsy core within minutes, without damaging the tissue. In this study, every biopsy core from men undergoing standard combined (targeted plus systematic) prostate biopsy will be scanned with this device immediately after removal, and the result will be compared with the final conventional pathology report of the very same core. The device result will not be used to guide any patient care. The study will measure how accurate the device is and simulate how many systematic biopsies could safely be avoided in the future if a positive device reading were used to stop further sampling.
Official title: Fluorescence Microscope for Localized Assessment and Sparing of Histology in Prostate Cancer (FLASH): An International, Multicentre, Prospective Diagnostic Accuracy and Clinical Utility Study With Blinded Index-Test and Reference-Standard Readers
Key Details
Gender
MALE
Age Range
40 Years - Any
Study Type
OBSERVATIONAL
Enrollment
450
Start Date
2026-12-01
Completion Date
2029-01-01
Last Updated
2026-09-29
Healthy Volunteers
No
Interventions
Ex vivo real-time fluorescence microscopy of prostate biopsy cores (EndoScell system, model MES-1000P)
Fresh biopsy cores are stained with fluorescein sodium (30 s) and methylene blue (30 s), scanned in contact mode within 5 minutes per core, and categorised on a three-tier scale; the tissue then proceeds to routine FFPE histopathology unchanged. The test is performed on excised tissue only and does not influence clinical management.