Clinical Trial

Targeted Biopsy, Rapid Pathology, and Immediate Surgery in USTC High-Risk Prostate Cancer: A Prospective Multicenter Study

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Summary
This multicenter, prospective, single-arm study evaluates a novel streamlined pathway for men at high risk of clinically significant prostate cancer (csPCa) identified by the USTC model (probability ≥0.60). Under general anesthesia, participants undergo MRI/ultrasound fusion targeted biopsy; the cores are immediately analyzed by frozen section hematoxylin-eosin staining and rapid immunohistochemistry. If csPCa is confirmed intraoperatively, laparoscopic radical prostatectomy is performed during the same anesthesia session. The primary aims are to determine the diagnostic concordance between intraoperative rapid pathology and definitive paraffin pathology, the positive surgical margin rate at 12 months, and perioperative safety. The study enrolls 150 participants across 12 Chinese hospitals and is expected to provide evidence supporting an efficient, PET-independent, one-stage diagnostic-therapeutic strategy for clinically significant prostate cancer.
Trial Details
NCT Number NCT07709338
Lead Sponsor Anhui Provincial Hospital
Conditions Prostate Cancer
Enrollment 150 participants
Start Date 2026-08-01
Primary Completion 2027-08-01 (estimated)
Study Completion 2028-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-16