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Идёт набор NCT06992232

Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC

Фаза II С лечением Prostate Cancer Metastatic Disease

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: Intense androgen deprivation therapy, Radiation Therapy, radical prostatectomy.
Кому может быть актуально
Состояния в реестре: Prostate Cancer Metastatic Disease. 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

Radiotherapy or Radical Prostatectomy Combined With Intense Androgen Deprivation Therapy for Newly Diagnosed Metastatic Prostate Cancer: A Multi-center Randomized Controlled Phase II Trial

Обзор

This multi-center randomized controlled phase II trial was carried out in several hospitals in China to evaluate the efficacy and safety of radiotherapy or radical prostatectomy combined with intense androgen deprivation therapy for newly diagnosed metastatic prostate cancer.

Вмешательства

  • Препарат Intense androgen deprivation therapy
    Patients received ADT plus second-generation ARi (enzalutamide, apalutamide, darolutamide or rezvilutamide) for 2 years.
  • Лучевая терапия Radiation Therapy
    Those allocated radiotherapy received 70Gy/2.8Gy/25f schedule for primary tumor and 70Gy/2.6-2.8Gy/25f or 37.5Gy/7.5Gy/5f for metastatic lymph nodes and bone lesions based on the size and location. Radiation should be finished within 2 years' systemic therapy.
  • Процедура radical prostatectomy
    Those allocated surgery received robot-assisted laparoscopic radical prostaectomy plus extended pelvic lymph node dissection for local treatment. Surgery should be finished within 2 years' systemic therapy.

Первичные конечные точки

  • Event-free Survival [Срок оценки: 2 years]
Вторичные конечные точки (3)
  • progression-free survival [Срок оценки: 4 years]
  • Time to CRPC [Срок оценки: 4 years]
  • Adverse events [Срок оценки: 4 years]

Критерии участия

Критерии включения

  • Histologically or cytologically confirmed prostate adenocarcinoma, with distant metastasis diagnosed by novel imaging modalities (PSMA PET/CT or PSMA PET/MR), involving ≤10 metastatic sites (amenable to local therapy) and without visceral metastasis.
  • The primary lesion is deemed resectable, or can achieve a resectable state following IADT.
  • Non-castration range (≥50 ng/dl), or the duration of testosterone levels in the castration range is no more than 3 months.
  • Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.
  • Patients must have adequate hematologic function, hepatic function and renal function.
  • Patients must participate voluntarily and sign an informed consent form(ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol.
  • Fertile patients must be willing to use highly effective contraception during the study period.

Критерии исключения

  • Patients with prostatic histopathology exhibiting neuroendocrine, small cell, or sarcomatoid features.
  • The researchers assessed the primary lesion as unresectable.
  • Patients who had previously received androgen deprivation therapy (including medical or surgical castration) for more than 3 months, or had undergone focal therapy for prostate cancer, or had received radiotherapy or chemotherapy for prostate cancer.
  • Patients with severe or uncontrolled underlying diseases who could not tolerate surgery or radiotherapy.
  • Patients with New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina, or a history of myocardial infarction within the past 6 months.
  • Uncontrolled severe hypertension, persistently uncontrolled diabetes, oxygen-dependent pulmonary disease, chronic liver disease, or HIV infection.
  • Within the past 5 years, having had other malignant tumors except for prostate cancer, with the exception of cured basal or squamous cell skin cancer.
  • Suffering from mental illness, mental disability, or being incapable of providing informed consent.

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
  • Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institut — Нанкин

Идентификаторы

NCT: NCT06992232 · IUNU-PC-122

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗