Real-time Fluorescence Microscopy for Intraoperative Assessment of Prostate Biopsy Cores (FLASH)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age40+
SponsorShanghai East Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >= 40 years;
Serum total PSA > 4.0 ng/mL and/or abnormal digital rectal examination;
Biopsy-naïve;
Pre-biopsy 3.0-T multiparametric MRI demonstrating at least one suspicious lesion (PI-RADS v2.1 score 3-5);
Disqualifiers
Prior treatment for prostate cancer (surgery, radiotherapy, focal therapy, or androgen-deprivation therapy), or use of 5-alpha-reductase inhibitors within the preceding 6 months;
Acute prostatitis or active urinary tract infection;
Contraindications to MRI (e.g., incompatible implants, severe claustrophobia);
Severe coagulation disorders or uncorrectable bleeding tendency;
Trial population
patients who suspected to have prostate cancer
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ex vivo real-time fluorescence microscopy of prostate biopsy cores (EndoScell system, model MES-1000P)
Diagnostic testFresh 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.
Treatment groups
450 Participants
are divided into 1 treatment groupGroup A: Biopsy-naïve men with suspected prostate cancer1 intervention
Trial outcomes
Primary outcomes
1
Patient-level sensitivity of the EndoScell system for clinically significant prostate cancer
Proportion of reference-positive participants (any core with ISUP grade group \>=2 on FFPE histopathology) with at least one core read as Category 1 (suspected clinically significant prostate cancer) on the index test; reported with exact (Clopper-Pearson) 95% confidence interval in the intention-to-diagnose population.
Time frame
Index test on Day 0; reference standard completed Day 7-142
Patient-level negative predictive value (NPV) of the EndoScell system
Proportion of participants with no Category 1 core who are reference-negative; exact 95% CI.
Time frame
Index test on Day 0; reference standard completed Day 7-143
Patient-level positive predictive value (PPV) of the EndoScell system
Proportion of participants with at least one Category 1 core who are reference-positive (ISUP grade group \>=2 on FFPE); exact 95% CI.
Time frame
Index test on Day 0; reference standard completed Day 7-144
Patient-level specificity of the EndoScell system for clinically significant prostate cancer
Proportion of reference-negative participants with no core read as Category 1; equivocal (Category 2) readings are grouped with test-negative in the primary analysis, with worst-case/best-case/exclusion sensitivity analyses prespecified; exact 95% CI.
Time frame
Index test on Day 0; reference standard completed Day 7-14Secondary outcomes
1
Core-level diagnostic concordance
Per-core sensitivity, specificity, PPV and NPV of the index test against FFPE histopathology, overall and stratified by core origin (targeted vs systematic), with cluster-robust 95% CIs from a generalised estimating equation (logit link, exchangeable correlation) accounting for within-patient clustering.
Time frame
Index test on Day 0; reference standard completed Day 7-142
Biopsy-sparing rate of the simulated "Positive-then-Stop" pathway
Proportion of participants in whom systematic biopsy would have been omitted (any targeted core read as Category 1), and the corresponding proportion of systematic cores avoided; prespecified deterministic simulation, exact 95% CIs. Hypothesis-generating; does not alter patient care.
Time frame
Simulation performed after database lock (estimated December 2028)3
Overdiagnosis reduction in the simulated pathway
Number and proportion of ISUP grade group 1 diagnoses that would have been averted by omitting systematic biopsy after a positive intraoperative reading; exact 95% CI.
Time frame
Simulation performed after database lock (estimated December 2028)4
Clinically significant prostate cancer miss rate in the simulated pathway
Number and proportion of reference-positive participants who would have been missed under the simulated pathway (targeted cores negative on both index test and FFPE, with csPCa found only in systematic cores); exact 95% CI.
Time frame
Simulation performed after database lock (estimated December 2028)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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