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.
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Single group
Targeted Biopsy, Intraoperative Rapid Pathology, and Immediate Radical Prostatectomy (FROST-RP)
Procedure/SurgeryIntegrated 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.
Positive Predictive Value (PPV) of intraoperative frozen section combined with rapid immunohistochemistry for clinically significant prostate cancer (csPCa)
PPV is defined as the proportion of participants who are diagnosed with csPCa by intraoperative frozen section and rapid immunohistochemistry and undergo immediate radical prostatectomy, in whom postoperative paraffin-embedded pathology (the gold standard) confirms the presence of csPCa. The target PPV is set at ≥95%.
Positive surgical margin rate
The proportion of participants with cancer involvement at the surgical margin on postoperative paraffin pathology.
Concordance of ISUP grade between intraoperative rapid pathology and postoperative paraffin pathology Concordance of ISUP grade between intraoperative rapid pathology and postoperative paraffin pathology
Weighted Kappa coefficient for the agreement of ISUP grade groups assessed by intraoperative frozen section plus rapid immunohistochemistry versus postoperative paraffin pathology.
Perioperative complication rate
The proportion of participants experiencing any perioperative complication, graded according to the Clavien-Dindo classification
Rate of serious adverse events (SAEs)
The proportion of participants experiencing any SAE, defined and graded according to CTCAE version 5.0.
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