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

23. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

450

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

40 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Männlich

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

patients who suspected to have prostate cancer

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: COHORT
  • Zeitperspektiven: PROSPECTIVE

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Diagnosetest: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Patient-level sensitivity of the EndoScell system for clinically significant prostate cancer
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Core-level diagnostic concordance
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Shanghai East Hospital

Ermittler

  • Studienstuhl: haifeng wang, Changhai Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Dezember 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2028

Studienabschluss (Geschätzt)

1. Januar 2029

Studienanmeldedaten

Zuerst eingereicht

23. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. September 2026

Zuerst gepostet (Tatsächlich)

29. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026304

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

IPD-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

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

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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