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Идёт набор NCT07115992

Efficacy and Safety of Radical Prostatectomy (RP) With or Without Salvage Radiotherapy Versus RP With Extended Pelvic Lymph Node Dissection for Localized Intermediate- and High-risk Prostate Cancer With a Briganti Nomogram≥7%

Без фазы С лечением Prostate Cancer Prostate Adenoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: RARP±SRT, RARP+ePLND.
Кому может быть актуально
Состояния в реестре: Prostate Cancer, Prostate Adenoma. Базовые параметры: 18 лет — 80 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Efficacy and Safety of Radical Prostatectomy (RP) With or Without Salvage Radiotherapy Versus RP With Extended Pelvic Lymph Node Dissection for Localized Intermediate- and High-risk Prostate Cancer With a Briganti Nomogram≥7%: an Open-label, Single-center, Non-inferiority Randomized Controlled Study

Обзор

The goal of this clinical trial is to evaluate efficacy and safety of radical prostatectomy (RP) with or without salvage radiotherapy versus RP with extended pelvic lymph node dissection (ePLND) in males who have localized intermediate/high-risk prostate cancer with a Briganti nomogram no less than 7%. The main questions this study aim to answer are: 1. Is RP with or without salvage radiotherapy non-inferior to RP with ePLND in efficacy for patients with localized intermediate/high-risk prostate cancer with a Briganti nomogram no less than 7%? 2. Will complication rates of RP with or without salvage radiotherapy be significantly lower than those of RP with ePLND? Researchers will compare the experimental arm (robot-assisted laparoscopic radical prostatectomy with or without salvage radiotherapy) versus the control arm (robot-assisted laparoscopic radical prostatectomy with ePLND) to see if differences exist in oncological efficacy and safety outcomes. Participants will: 1. Undergo one of the following surgical interventions: 1. Robot-assisted laparoscopic radical prostatectomy (RARP) with extended pelvic lymph node dissection (ePLND), OR 2. RARP alone, followed by salvage radiotherapy only if biochemical recurrence occurs postoperatively 2. Complete scheduled monitoring activities: 1. Serum PSA testing: Monthly or every 3 months within 2 years after surgery 2. PSMA PET/CT scans: Annually until study completion 3. Report all treatment-related complications within 24 hours of onset

Вмешательства

  • Процедура RARP±SRT
    Participants will undergo robot-assisted radical prostatectomy (RARP). Upon biochemical recurrence, they will receive salvage radiotherapy: 52.5-62.5 Gy in 20-25 fractions/2.5-3.0 Gy per fraction, per 2025 AUA/ASTRO/SUO guidelines.
  • Процедура RARP+ePLND
    Participants will undergo robot-assisted radical prostatectomy (RARP) with extended pelvic lymph node dissection (ePLND), encompassing bilateral removal of obturator, external iliac, internal iliac, and common iliac lymph nodes. The dissection field extends laterally to the genitofemoral nerve, medially to the bladder wall, proximally to the ureter crossing the common iliac vessels, and distally to the deep circumflex iliac vein and femoral canal.

Первичные конечные точки

  • 2-year Biochemical-recurrence Free Survival rate (2-year BFS) [Срок оценки: 2 years from randomization]
Вторичные конечные точки (4)
  • PSA doubling time, PSADT [Срок оценки: baseline and 2 years]
  • Radiographic progression-free survival, rPFS [Срок оценки: 2 years from randomization]
  • Time to First biochemical recurrence (BCR) event in the experimental group [Срок оценки: 2 years from randomization]
  • Overall survival, OS [Срок оценки: 2 years from randomization]

Критерии участия

Критерии включения

  • Provided signed and dated informed consent form.
  • Be male aged 18-80 years at consent.
  • Commit to protocol compliance and complete all study procedures.
  • Medically fit to tolerate interventions, including PSMA PET imaging, RARP, pelvic radiotherapy.
  • Diagnosis of localized intermediate/high-risk prostate cancer (miN0M0):

i. Confirmed by: systematic biopsy + PSA + PSMA PET/MRI. ii. Briganti nomogram (2017)≥7%. iii. Candidate for radical prostatectomy. iv. D'Amico:

  • Intermediate-risk: PSA 10-20ng/mL OR Gleason 7 (ISUP Grade 2/3) OR cT2b;
  • High-risk: PSA>20ng/mL OR Gleason>7 (ISUP Grade 4/5) OR cT2c.

Критерии исключения

  • Prior treatments for prostate cancer, including radiotherapy, chemotherapy or endocrine therapy.
  • Non-acinar adenocarcinoma histology on biopsy.
  • Preoperative evidence of metastasis: nodal(N1), locally advanced(T3-4), or distant(M1) disease on imaging.
  • History of pelvic lymphadenectomy or radiotherapy.
  • Other malignancies within 5 years.
  • Contraindications to radical prostatectomy or being deemed surgically inoperable upon clinical assessment.
  • Contraindications to radiotherapy or intolerance determined by radiation oncologists.
  • Severe allergy to PSMA PET ligands or excipients.
  • Any other conditions precluding PSMA PET examination.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Ruijin hospital — Шанхай

Идентификаторы

NCT: NCT07115992 · 2025-423

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗