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

NCT07846592 | Not Yet Recruiting DMC

• 1 other identifier: 2026304
• Study Type: observational
• Target: 450
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Prostate Cancer (Diagnosis); Prostatic Neoplasms

Keywords

fluorescence microscopy; diagnostic accuracy; prostate biopsy; multiparametric MRI; clinically significant prostate cancer; overdiagnosis; STARD

Outcome Measures

Primary Outcomes (4)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (8)

• Core-level diagnostic concordance

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

• Biopsy-sparing rate of the simulated "Positive-then-Stop" pathway

  Simulation performed after database lock (estimated December 2028)

• Overdiagnosis reduction in the simulated pathway

  Simulation performed after database lock (estimated December 2028)

• Clinically significant prostate cancer miss rate in the simulated pathway

  Simulation performed after database lock (estimated December 2028)

• Net benefit of the simulated pathway (decision-curve analysis)

  Simulation performed after database lock (estimated December 2028)

Study Arms (1)

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.

Diagnostic Test: Ex vivo real-time fluorescence microscopy of prostate biopsy cores (EndoScell system, model MES-1000P)

Interventions

Ex vivo real-time fluorescence microscopy of prostate biopsy cores (EndoScell system, model MES-1000P) DIAGNOSTIC_TEST

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.

Biopsy-naïve men with suspected prostate cancer

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients who suspected to have prostate cancer

You may qualify if:

• 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);
• Fit for transperineal or transrectal prostate biopsy under local, regional, or general anaesthesia;
• Written informed consent.

You may not qualify if:

• 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;
• History of major anorectal surgery precluding safe insertion of the endorectal ultrasound probe (where transrectal guidance is used);
• Any other condition that, in the investigator's judgement, makes the participant unsuitable for the trial.

Sponsors & Collaborators

• Shanghai East Hospital: lead

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• haifeng wang

  Changhai Hospital

  STUDY CHAIR

Central Study Contacts

biming He

CONTACT

15502139410; 190589109@qq.com

haifeng wang

CONTACT

86-13681750891; 190589109@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 12 months after publication of the primary results, for a period of 5 years.
• Access Criteria: Proposals will be reviewed by the Trial Steering Committee; access requires approval and a data-access agreement.