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Идёт набор NCT06825091

Is Adaptive SBRT for Prostate vs Image-guided Radiotherapy a True Evolution (ASPIRE)

Фаза III С лечением Localized Prostate Cancer Stereotactic Body Radiotherapy

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: SBRT.
Кому может быть актуально
Состояния в реестре: Localized Prostate Cancer, Stereotactic Body Radiotherapy. Базовые параметры: от 18 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
Канада
Следующий шаг
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Обзор

The ASPIRE study is a Phase III randomized, single-center study designed to evaluate whether adaptive stereotactic body radiotherapy (SBRT) offers superior clinical benefits compared to standard image-guided SBRT for patients with localized prostate cancer. It aims to explore whether adaptive SBRT can improve urinary outcomes while maintaining effective cancer control. This interventional study is randomized, single-institution, and includes 320 participants with localized prostate cancer. Patients will be stratified based on fractionation schedules (5 vs. 7 fractions), use of rectal spacers, androgen deprivation therapy (ADT), and baseline alpha receptor antagonist use. Participants will be randomized to receive either adaptive SBRT or standard image-guided SBRT, with both arms adhering to established dosing protocols. Inclusion criteria includes an age greater than 18 years, diagnosed with localized prostate adenocarcinoma, and an ECOG performance status of 0-1, Eligible for prostate SBRT. The exclusion criteria includes patients who plan for elective nodal irradiation and contraindications to radiotherapy or MRI (for MR-Linac patients).

Вмешательства

  • Лучевая терапия SBRT
    Standard of care SBRT (36.25 Gy in 5 fractions or 42.7 Gy in 7 fractions) for localized prostate cancer, delivered either via an adaptive or a non-adaptive image-guided treatment. Androgen deprivation therapy use and duration is at the discretion of the treating physician and patient, in accordance with standard practice based on patients' prostate cancer risk group.

Первичные конечные точки

  • To determine whether adaptive SBRT can significantly reduce the proportion of patients experiencing a minimal clinically important difference in patient reported urinary domain changes when compared to the non adaptive image guided SBRT group. [Срок оценки: Within 3 months following radiation therapy]
Вторичные конечные точки (9)
  • To determine whether adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate results in different rates of patient reported outcomes, acute toxicity. [Срок оценки: Within 3 months of radiation therapy]
  • To determine whether adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate results in different rates of patient reported outcomes, acute toxicity. [Срок оценки: Within 3 months of radiation therapy]
  • To determine whether adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate results in different rates of patient reported outcomes, acute toxicity. [Срок оценки: Within 3 months of radiation therapy]
  • To determine whether adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate results in different rates of patient- reported outcomes, acute toxicity. [Срок оценки: Within 3 months of radiation therapy]
  • To determine whether adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate results in different rates of patient- reported outcomes at 2 years, late toxicity. [Срок оценки: 2 years following radiation.]
  • To determine whether adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate results in different rates of patient- reported outcomes at 2 years, late toxicity. [Срок оценки: 2 years following radiation]
  • To determine whether adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate results in different cumulative incidence of biochemical failure and distant metastases. [Срок оценки: Within 3 months of radiation therapy]
  • To determine whether adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate results in different cumulative incidence of biochemical failure and distant metastases. [Срок оценки: 2 years following radiation]
  • To determine the economic impact of adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate. [Срок оценки: 2 years following radiation]

Критерии участия

Критерии включения

  • Age >18 years
  • Histologic diagnosis of prostate adenocarcinoma
  • Localized prostate cancer
  • Low risk, intermediate risk, or high risk allowed
  • Patient planned for prostate SBRT

Критерии исключения

  • Planned for elective nodal irradiation
  • Contraindications to radiotherapy
  • Patients with bilateral hip replacements, as they are ineligible for adaptive treatments at present time (either MR-guided or CT-guided)

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
Организация здравоохранения

Центры проведения

Канада · 1 центр
  • Princess Margaret Cancer Center — Toronto

Идентификаторы

NCT: NCT06825091 · 24-5757

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗