Clinical trial · Observational
Real-time Fluorescence Microscopy for Intraoperative Assessment of Prostate Biopsy Cores (FLASH)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer (Diagnosis) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ex vivo real-time fluorescence microscopy of prostate biopsy cores (EndoScell system, model MES-1000P) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Biopsy-naïve men with suspected prostate cancer
- description
- Men undergoing standard-of-care combined targeted plus systematic prostate biopsy; every core undergoes ex vivo EndoScell fluorescence microscopy (index test) followed by FFPE histopathology (reference standard). Device results are not used for patient care.
- interventionNames
- Diagnostic Test: Ex vivo real-time fluorescence microscopy of prostate biopsy cores (EndoScell system, model MES-1000P)
Primary outcomes (4)
- measure
- Patient-level sensitivity of the EndoScell system for clinically significant prostate cancer
- timeFrame
- Index test on Day 0; reference standard completed Day 7-14
- description
- 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.
- measure
- Patient-level negative predictive value (NPV) of the EndoScell system
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \>= 40 years; 2. Serum total PSA \> 4.0 ng/mL and/or abnormal digital rectal examination; 3. Biopsy-naïve; 4. Pre-biopsy 3.0-T multiparametric MRI demonstrating at least one suspicious lesion (PI-RADS v2.1 score 3-5); 5. Fit for transperineal or transrectal prostate biopsy under local, regional, or general anaesthesia; 6. Written informed consent. Exclusion Criteria: 1. 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; 2. Acute prostatitis or active urinary tract infection; 3. Contraindications to MRI (e.g., incompatible implants, severe claustrophobia); 4. Severe coagulation disorders or uncorrectable bleeding tendency; 5. History of major anorectal surgery precluding safe insertion of the endorectal ultrasound probe (where transrectal guidance is used); 6. Any other condition that, in the investigator's judgement, makes the participant unsuitable for the trial.
References
Publications (0)
Data not yet available