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Comparing a New Fluorescence Staining Method With Frozen Section in Prostate Cancer Surgery

Compares a new fluorescence staining test with frozen section for diagnosing prostate cancer.

Plain-language title generated from the registry record
Registry title: Infrared Fluorescence Staining Versus Frozen Section for Prostate Cancer Surgery

Key facts

Where
Changsha, ChinaSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult men who are scheduled for a prostate biopsy because prostate cancer is suspected. It tests a new fast staining method on the biopsy samples.

Age
18 years or older
Sex
Men only
Disease stage
Suspected prostate cancer, for example raised PSA, an abnormal rectal examination, or suspicious spots on imaging.

Main reasons for not taking part

  • Acute infection or fever
  • Severe bleeding tendency, so biopsy is not possible
  • Serious illness that could affect the results or raise risk, such as hypertensive crisis or decompensated cardiac insufficiency
  • Severe hemorrhoids, or perianal or rectal lesions
  • Heart, lung, liver, kidney or clotting function that is not essentially normal

Read by machine on 13 November 2026.

Where in China

  • Xiangya Hospital Central South UniversityChangsha, ChinaContact: Yi Cai, DoctorNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Xiangya Hospital of Central South University
Trial code
NCT07690462
Record updated
8 July 2026
Original description
This study aims to validate the accuracy of the infrared fluorescence rapid detection technique for the diagnosis of prostate biopsy specimens, and to compare it with intraoperative frozen section and conventional paraffin section (the gold standard), so as to evaluate its feasibility and value in clinical application.Read full original descriptionShow less

A Clinical Validation Study of Novel Infrared Fluorescence Rapid Staining Versus Conventional Frozen Section in Intraoperative Diagnosis of Prostate Cancer

This study aims to validate the accuracy of the infrared fluorescence rapid detection technique for the diagnosis of prostate biopsy specimens, and to compare it with intraoperative frozen section and conventional paraffin section (the gold standard), so as to evaluate its feasibility and value in clinical application.

Inclusion: All adult male patients who are scheduled to undergo prostate biopsy at the Department of Urology, Xiangya Hospital due to clinical suspicion (e.g., elevated PSA, abnormal digital rectal examination, or suspicious lesions on imaging); Patients whose cardiac, pulmonary, hepatic, renal, and coagulation functions are essentially normal and who are able to tolerate the biopsy procedure; The patient or their legally authorized representative has signed the written informed consent form.

Exclusion: Patients with any serious concomitant disease that, in the investigator's opinion, may interfere with the study results or increase the patient's risk (e.g., hypertensive crisis; decompensated cardiac insufficiency; severe internal or external hemorrhoids, perianal or rectal lesions, etc.); Patients in the acute infection phase or febrile period; Patients with severe bleeding tendency conditions who are unable to undergo biopsy.

ClinicalTrials.gov NCT07690462