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

Official record

Identifier

NCT07846592

Recruiting locations

Locations are not included in the offline baseline for this record. Open the official record to see the current site list.

Interventions studied

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

Lead sponsor

Shanghai East Hospital

Target enrolment

450 participants

Study type

OBSERVATIONAL

Phase

Not provided in the official record

Status

Not yet recruiting

First posted

Sep 29, 2026

Last updated on the registry

Sep 29, 2026

Age

40 Years

Sex

MALE

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Prostate Cancer