Is Adaptive SBRT for Prostate vs Image-guided Radiotherapy a True Evolution (ASPIRE)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Histologic diagnosis of prostate adenocarcinoma
- •Localized prostate cancer
- •Low risk, intermediate risk, or high risk allowed
- •Patient planned for prostate SBRT
排除标准
- •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)
研究组 & 干预措施
Non-adaptive image-guided SBRT
Patients will receive prostate SBRT. A dose of either 36.25 Gy in 5 fractions (per PACE-B trial) or 42.7 Gy in 7 fractions (per HYPO-RT-PC trial) will be prescribed as per standard practice at PMH. Patients will receive SBRT every other day, excluding weekends and holidays, as per standard practice. Patients will undergo radiotherapy simulation as per standard practice with CT and MR simulation (or without MR if contraindication).
干预措施: SBRT (Radiation)
Adaptive SBRT
Patients will receive prostate SBRT. A dose of either 36.25 Gy in 5 fractions (per PACE-B trial) or 42.7 Gy in 7 fractions (per HYPO-RT-PC trial) will be prescribed as per standard practice. Patients will receive SBRT every other day, excluding weekends and holidays, as per standard practice. Patients will undergo radiotherapy simulation as per standard practice with CT and MR simulation (or without MR if contraindication).
干预措施: SBRT (Radiation)
结局指标
主要结局
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.
时间窗: Within 3 months following radiation therapy
To determine whether adaptive SBRT can significantly reduce the proportion of patients experiencing a minimal clinically important difference (MCID; defined as \>10-point change) in patient reported urinary domain changes by EPIC-26 (The Expanded Prostate Cancer Index Composite) questionnaire. within 3-months following radiation when compared to the non-adaptive image guided SBRT group
次要结局
- 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.(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.(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.(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.(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.(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.(2 years following radiation)
- To determine the economic impact of adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate.(2 years following radiation)