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Targeted Biopsy, Rapid Pathology, and Immediate Surgery in USTC High-Risk Prostate Cancer: A Prospective Multicenter Study
Sponsor: Anhui Provincial Hospital
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.
Official title: A Multicenter, Prospective, Single-Arm Clinical Trial Evaluating MRI/Ultrasound Fusion Targeted Biopsy With Intraoperative Frozen Section and Rapid Immunohistochemistry Followed by Immediate Laparoscopic Radical Prostatectomy in Patients With High-Risk Prostate Cancer Identified by the USTC Model
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-08-01
Completion Date
2028-08-01
Last Updated
2026-07-16
Healthy Volunteers
No
Conditions
Interventions
Targeted Biopsy, Intraoperative Rapid Pathology, and Immediate Radical Prostatectomy (FROST-RP)
Integrated diagnostic-therapeutic pathway: 1) preoperative risk stratification by USTC nomogram (PSAD + PI-RADS); 2) general anesthesia and MRI/ultrasound fusion targeted biopsy; 3) intraoperative frozen HE and rapid IHC (P504s, p63, CK5/6); 4) if csPCa is diagnosed, immediate laparoscopic radical prostatectomy under the same anesthesia; otherwise, only the biopsy procedure is performed.