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Real-time Fluorescence Microscopy for Intraoperative Assessment of Prostate Biopsy Cores (FLASH) (FLASH)

23 settembre 2026 aggiornato da: Shanghai East Hospital

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

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

FLASH is an investigator-initiated, international, multicentre, prospective diagnostic-accuracy and clinical-utility study with a within-patient paired design, conducted and reported in accordance with STARD 2015. Biopsy-naïve men with suspected prostate cancer (serum PSA >4 ng/mL and/or abnormal digital rectal examination) and at least one MRI-visible lesion (PI-RADS v2.1 score 3-5) will undergo standard-of-care combined targeted and systematic prostate biopsy.

Immediately after extraction, every core will undergo ex vivo dual staining (fluorescein sodium for 30 seconds followed by methylene blue for 30 seconds) and contact-mode scanning with the EndoScell real-time fluorescence microscope (model MES-1000P), completed within 5 minutes per core by certified technicians. Each core is assigned to a three-tier category (0 = negative/suspected low-grade; 1 = suspected clinically significant prostate cancer; 2 = equivocal). The interval from core extraction to formalin fixation will not exceed 15 minutes. All cores then undergo routine formalin-fixed paraffin-embedded (FFPE) histopathology with haematoxylin and eosin staining, with immunohistochemistry as clinically indicated, reported by senior uropathologists.

Bidirectional blinding is enforced throughout: technicians are blinded to all clinical data, MRI findings, and core origin; device results are withheld from the treating team and never enter the medical record; uropathologists are blinded to all device data; the statistician works with coded variables until database lock. Central pathology review is performed for discordant and equivocal cases.

The primary outcome is patient-level diagnostic accuracy (sensitivity, specificity, positive and negative predictive values with exact 95% confidence intervals) of the device for clinically significant prostate cancer (ISUP grade group >=2) against FFPE histopathology in the intention-to-diagnose population. Secondary outcomes include core-level concordance with cluster adjustment, inter-reader reproducibility, tissue-integrity assessment, operational metrics, and a prespecified decision-analytic simulation of a "Positive-then-Stop" biopsy-sparing pathway, which is hypothesis-generating and does not alter patient care. The accuracy and utility estimates are intended to inform the design of a future randomised de-implementation trial.

Tipo di studio

Osservativo

Iscrizione (Stimato)

450

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

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Criteri di ammissibilità

Età idonea allo studio

40 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Metodo di campionamento

Campione di probabilità

Popolazione di studio

patients who suspected to have prostate cancer

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: COHORT
  • Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Biopsy-naïve men with suspected prostate cancer

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.
Test diagnostico: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient-level sensitivity of the EndoScell system for clinically significant prostate cancer
Lasso di tempo: Index test on Day 0; reference standard completed Day 7-14

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.
Index test on Day 0; reference standard completed Day 7-14
Patient-level negative predictive value (NPV) of the EndoScell system
Lasso di tempo: Index test on Day 0; reference standard completed Day 7-14

Proportion of participants with no Category 1 core who are reference-negative; exact 95% CI.
Index test on Day 0; reference standard completed Day 7-14
Patient-level positive predictive value (PPV) of the EndoScell system
Lasso di tempo: Index test on Day 0; reference standard completed Day 7-14

Proportion of participants with at least one Category 1 core who are reference-positive (ISUP grade group >=2 on FFPE); exact 95% CI.
Index test on Day 0; reference standard completed Day 7-14
Patient-level specificity of the EndoScell system for clinically significant prostate cancer
Lasso di tempo: Index test on Day 0; reference standard completed Day 7-14

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.
Index test on Day 0; reference standard completed Day 7-14

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Core-level diagnostic concordance
Lasso di tempo: Index test on Day 0; reference standard completed Day 7-14

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.
Index test on Day 0; reference standard completed Day 7-14
Biopsy-sparing rate of the simulated "Positive-then-Stop" pathway
Lasso di tempo: Simulation performed after database lock (estimated December 2028)

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.
Simulation performed after database lock (estimated December 2028)
Overdiagnosis reduction in the simulated pathway
Lasso di tempo: Simulation performed after database lock (estimated December 2028)

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.
Simulation performed after database lock (estimated December 2028)
Clinically significant prostate cancer miss rate in the simulated pathway
Lasso di tempo: Simulation performed after database lock (estimated December 2028)

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.
Simulation performed after database lock (estimated December 2028)
Net benefit of the simulated pathway (decision-curve analysis)
Lasso di tempo: Simulation performed after database lock (estimated December 2028)

Decision-curve analysis with patient-level bootstrap (1000 resamples) comparing three strategies (combined biopsy for all; targeted biopsy alone; Positive-then-Stop) across threshold probabilities.
Simulation performed after database lock (estimated December 2028)
Inter-reader agreement of index-test readings
Lasso di tempo: Video re-reading after completion of enrolment (estimated 2028)

Cohen's kappa (three-tier scale and dichotomised Category 1 vs 0/2) and percent agreement between two blinded technicians re-interpreting a random 20% subset of archived scan videos (~900-1200 cores).
Video re-reading after completion of enrolment (estimated 2028)
Tissue-integrity (tissue-compromise) rate
Lasso di tempo: Day 7-14 (pathology reporting)

Proportion of cores flagged by uropathologists as degraded, unreadable, or inadequate for definitive H&E/IHC evaluation attributable to the staining/scanning procedure; one-sided upper 95% confidence bound compared against the 1% acceptability benchmark.
Day 7-14 (pathology reporting)
Operational performance of the index test
Lasso di tempo: Day 0

Per-core scanning time, extraction-to-fixation interval, equivocal (Category 2) rate, and device/scan failure rate, summarised descriptively by centre and calendar quarter.
Day 0

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Shanghai East Hospital

Investigatori

  • Cattedra di studio: haifeng wang, Changhai Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 dicembre 2026

Completamento primario (Stimato)

1 dicembre 2028

Completamento dello studio (Stimato)

1 gennaio 2029

Date di iscrizione allo studio

Primo inviato

23 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 settembre 2026

Primo Inserito (Effettivo)

29 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026304

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

De-identified participant-level data and the signed statistical analysis plan will be made available on reasonable request to the corresponding author, subject to a methodologically sound proposal and a signed data-access agreement.

Periodo di condivisione IPD

Beginning 12 months after publication of the primary results, for a period of 5 years.

Criteri di accesso alla condivisione IPD

Proposals will be reviewed by the Trial Steering Committee; access requires approval and a data-access agreement.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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