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

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.

Inclusion Criteria: ① Patients with clinically suspected prostate cancer based on examination (e.g., DRE or PSA testing); ② Patients who have undergone serum tPSA testing and mpMRI; ③ 4 ng/mL ≤ tPSA \< 100 ng/mL; ④ Patients with a csPCa risk probability of ≥0.60 as assessed by the clinical prediction model (https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/); ⑤ The patient has no significant contraindications for prostate biopsy or radical prostatectomy. Exclusion Criteria: ① No complete serum tPSA test or mpMRI scan; ② tPSA \< 4 ng/mL or ≥ 100 ng/mL; ③ Based on assessment by a clinical prediction model, the patient's probability of csPCa is \< 0.60; ④ Patients with a history of multiple biopsies showing no evidence of clinically significant prostate cancer; ⑤ Patients in poor general health who cannot tolerate a biopsy; ⑥ Patients with severe bleeding disorders or those currently undergoing anticoagulant therapy.