NCT07846592Not yet recruiting
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 · Last updated 29 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 450 (estimated)
- First submitted
- 23 Sept 2026
- Start date
- Dec 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Shanghai East Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT07846592
What you commit to
- Study type: Observational
- Planned participants: 450
- From Dec 2026 to the primary completion date, Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Contraindications to MRI (e.g., incompatible implants, severe claustrophobia);
Other illness
- Acute prostatitis or active urinary tract infection;
- 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.
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: Male · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.