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

12 lipca 2026 zaktualizowane przez: Tao Tao, MD, Anhui Provincial Hospital

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

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Study Design and Setting This is a prospective, multicenter, single-arm, open-label clinical study conducted in 12 tertiary hospitals in China that have established multidisciplinary prostate cancer teams.

Screening and Enrollment Male patients with clinical suspicion of prostate cancer undergo serum total PSA testing and 3.0T multiparametric MRI. Prostatic volume is measured to calculate prostate-specific antigen density (PSAD), and the index lesion is scored using PI-RADS v2.1. These parameters are entered into the USTC online nomogram (https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/) to generate a predicted probability of clinically significant prostate cancer (csPCa). Patients with a predicted probability ≥0.60, who meet all eligibility criteria (PSA 4-100 ng/mL, at least one PI-RADS ≥3 lesion, ECOG 0-1, no contraindication to general anesthesia or radical prostatectomy, and no evidence of metastasis), are fully informed and asked to provide written consent. Enrolled participants proceed directly to the interventional pathway.

Intervention Under general anesthesia, MRI/ultrasound fusion targeted biopsy (2-4 cores from the index lesion) is performed. The cores are immediately submitted for frozen section hematoxylin-eosin staining and rapid immunohistochemistry (key antibodies: P63, P504s, CK5/6). A pathologist provides a report within 30-60 minutes.

If csPCa is diagnosed intraoperatively, the patient is repositioned and laparoscopic radical prostatectomy is completed under the same anesthesia session.

If rapid pathology returns benign tissue, atypical small acinar proliferation, high-grade prostatic intraepithelial neoplasia, or is non-diagnostic, the procedure is stopped; only the biopsy is performed, and further management follows standard care.

Endpoints and Follow-up Primary endpoints: Positive Predictive Value (PPV) of intraoperative frozen section combined with rapid immunohistochemistry for clinically significant prostate cancer (csPCa) Secondary endpoints: ① Positive surgical margin rate; ② Agreement rate between intraoperative rapid pathology and postoperative paraffin-embedded pathology according to the ISUP grading system. ② Biochemical recurrence rates at 3, 6, and 12 months postoperatively (defined as two consecutive postoperative serum PSA levels ≥ 0.2 ng/mL with an interval of at least 3 weeks; cumulative incidence will be calculated). ③ Incidence of perioperative complications. ③ Incidence of serious adverse events (SAEs). ④ Intraoperative blood loss (mL) and perioperative (intraoperative to 30 days postoperatively) transfusion rate. ⑤ Rehospitalization rate within 30 days postoperatively. ⑥ Urinary continence recovery rate at 3, 6, and 12 months postoperatively.

Follow-up visits occur at 30 days, 3, 6, and 12 months post-procedure. All data are captured via paper case report forms and managed centrally

Typ studiów

Interwencyjne

Zapisy (Szacowany)

150

Faza

  • Nie dotyczy

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Diagnostyczny
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Procedura: Targeted Biopsy, Intraoperative Rapid Pathology, and Immediate Radical Prostatectomy (FROST-RP)
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Positive Predictive Value (PPV) of intraoperative frozen section combined with rapid immunohistochemistry for clinically significant prostate cancer (csPCa)
Ramy czasowe: At the time of final paraffin pathology report (usually within 7-14 days after surgery)
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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Positive surgical margin rate
Ramy czasowe: At the time of final paraffin pathology report (usually within 7-14 days after surgery)
The proportion of participants with cancer involvement at the surgical margin on postoperative paraffin pathology.
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
Ramy czasowe: At the time of final paraffin pathology report (usually within 7-14 days after surgery)
Weighted Kappa coefficient for the agreement of ISUP grade groups assessed by intraoperative frozen section plus rapid immunohistochemistry versus postoperative paraffin pathology.
At the time of final paraffin pathology report (usually within 7-14 days after surgery)
Perioperative complication rate
Ramy czasowe: Up to 30 days after surgery
The proportion of participants experiencing any perioperative complication, graded according to the Clavien-Dindo classification
Up to 30 days after surgery
Rate of serious adverse events (SAEs)
Ramy czasowe: From the day of surgery through 12 months of follow-up
The proportion of participants experiencing any SAE, defined and graded according to CTCAE version 5.0.
From the day of surgery through 12 months of follow-up
Intraoperative blood loss and perioperative blood transfusion rate
Ramy czasowe: Intraoperative and up to 30 days after surgery
Volume of intraoperative blood loss (mL) and the proportion of participants receiving any blood transfusion during surgery or within 30 days postoperatively.
Intraoperative and up to 30 days after surgery
30-day readmission rate
Ramy czasowe: 30 days after initial discharge
The proportion of participants readmitted to the hospital for any cause within 30 days after discharge following the study procedure.
30 days after initial discharge
Urinary continence recovery rate Urinary continence recovery rate Urinary continence recovery rate
Ramy czasowe: 3, 6, and 12 months after surgery
The proportion of participants achieving urinary continence (defined as 24-hour urine pad weight <10 g) at 3, 6, and 12 months postoperatively.
3, 6, and 12 months after surgery

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Anhui Provincial Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 sierpnia 2026

Zakończenie podstawowe (Szacowany)

1 sierpnia 2027

Ukończenie studiów (Szacowany)

1 sierpnia 2028

Daty rejestracji na studia

Pierwszy przesłany

12 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 lipca 2026

Pierwszy wysłany (Rzeczywisty)

16 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • Frost-RP

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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