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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. 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).
2. Patients whose cardiac, pulmonary, hepatic, renal, and coagulation functions are essentially normal and who are able to tolerate the biopsy procedure.
3. The patient or their legally authorized representative has signed the written informed consent form.
Exclusion Criteria:
1. Patients in the acute infection phase or febrile period.
2. Patients with severe bleeding tendency conditions who are unable to undergo biopsy.
3. 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.).
Primary outcome measure(s)
Diagnostic accuracy of prostate biopsy specimens — At baseline (Single visit) To evaluate the diagnostic accuracy of the novel rapid infrared fluorescence staining technique for prostate biopsy specimens, and to compare it with frozen section.
Trial sites (1)
Facility
City
Region
Status
Xiangya Hospital Central South University
Changsha
Hunan
More Xiangya Hospital of Central South University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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