Clinical trial · Interventional
Targeted Biopsy, Rapid Pathology, and Immediate Surgery in USTC High-Risk Prostate Cancer: A Prospective Multicenter Study
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Targeted Biopsy, Intraoperative Rapid Pathology, and Immediate Radical Prostatectomy (FROST-RP) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- USTC Model-Guided Targeted Biopsy-Rapid Path-Immediate RP
- description
- 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.
- interventionNames
- Procedure: Targeted Biopsy, Intraoperative Rapid Pathology, and Immediate Radical Prostatectomy (FROST-RP)
Primary outcomes (1)
- measure
- Positive Predictive Value (PPV) of intraoperative frozen section combined with rapid immunohistochemistry for clinically significant prostate cancer (csPCa)
- timeFrame
- At the time of final paraffin pathology report (usually within 7-14 days after surgery)
- description
- 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%.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available