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

Sponsor
Anhui Provincial Hospital
Study ID
NCT07709338
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Targeted Biopsy, Intraoperative Rapid Pathology, and Immediate Radical Prostatectomy (FROST-RP) — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Jul 16, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Aug 1, 2027
Completion
Aug 1, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: USTC Model-Guided Targeted Biopsy-Rapid Path-Immediate RP
    Participants with USTC model-predicted csPCa probability ≥0.60 undergo general anesthesia and MRI/ultrasound fusion targeted biopsy (2-4 cores). Fresh cores are processed immediately for frozen HE and rapid IHC (P504s, p63, CK5/6). If intraoperative diagnosis is csPCa, immediate laparoscopic radical prostatectomy is performed in the same anesthesia. If pathology is benign, ASAP, HGPIN, or non-diagnostic, only the biopsy is completed and the participant follows standard care.

Primary Outcome Measure

Positive Predictive Value (PPV) of intraoperative frozen section combined with rapid immunohistochemistry for clinically significant prostate cancer (csPCa) [ Time Frame: At the time of final paraffin pathology report (usually within 7-14 days after surgery) ]

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