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

NCT07709338 | Not Yet Recruiting DMC

• 1 other identifier: Frost-RP
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Diagnosis; Targeted Biopsy,; Rapid Pathology; Immediate Surgery

Outcome Measures

Primary Outcomes (1)

• 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%.

  At the time of final paraffin pathology report (usually within 7-14 days after surgery)

Secondary Outcomes (7)

• Positive surgical margin rate

  At the time of final paraffin pathology report (usually within 7-14 days after surgery)

• Concordance of ISUP grade between intraoperative rapid pathology and postoperative paraffin pathology Concordance of ISUP grade between intraoperative rapid pathology and postoperative paraffin pathology

  At the time of final paraffin pathology report (usually within 7-14 days after surgery)

• Perioperative complication rate

  Up to 30 days after surgery

• Rate of serious adverse events (SAEs)

  From the day of surgery through 12 months of follow-up

• Intraoperative blood loss and perioperative blood transfusion rate

  Intraoperative and up to 30 days after surgery

Study Arms (1)

USTC Model-Guided Targeted Biopsy-Rapid Path-Immediate RP

EXPERIMENTAL

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.

Procedure: Targeted Biopsy, Intraoperative Rapid Pathology, and Immediate Radical Prostatectomy (FROST-RP)

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.

USTC Model-Guided Targeted Biopsy-Rapid Path-Immediate RP

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Associate chief physician

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-07