Infrared Fluorescence Staining Versus Frozen Section for Prostate Cancer Surgery

NCT07690462 | Not Yet Recruiting

• 1 other identifier: 2026040848
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of prostate biopsy specimens

  To evaluate the diagnostic accuracy of the novel rapid infrared fluorescence staining technique for prostate biopsy specimens, and to compare it with frozen section.

  At baseline (Single visit)

Study Arms (3)

Novel infrared fluorescence rapid staining group

Frozen section group

Paraffin section group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult male patients scheduled for prostate biopsy at Xiangya Hospital's Department of Urology. Participants must be in a generally stable condition to tolerate the procedure and have no significant comorbidities that would interfere with study assessments or pose additional risks.

You may qualify if:

• 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.

You may not qualify if:

• Patients in the acute infection phase or febrile period.
• Patients with severe bleeding tendency conditions who are unable to undergo biopsy.
• 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.).

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Yi Cai

CONTACT

+8613637310713; cai-yi@csu.edu.cn

Changchun Lin

CONTACT

+8618808942834; lincc0207@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)