A Phase I, Prospective, Single-Arm Feasibility Study: Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response (EASY)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Quantify adverse events using CTCAE v5.0
研究概览
简要总结
This prospective, single-arm feasibility study will include patients with prostate cancer that have controlled local disease diagnosed with oligorecurrent para-aortic nodal disease and/or common iliac nodal disease detected by PSMA PET or conventional CT/MRI imaging, and these patients will undergo CT-guided online adaptive SBRT to the tumor and elective SBRT to adjacent at-risk nodal regions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Histologically confirmed prostate adenocarcinoma.
- •Oligorecurrent para-aortic +/- common iliac nodal disease planned for SBRT.
- •≤10 involved para-aortic (defined as between L1/L2 interface and L4/L5 interface) +/- common iliac LN on PSMA PET imaging.
- •ECOG performance status 0-2.
排除标准
- •Prior radiotherapy to the nodal echelon (PA +/- common iliac).
- •Active secondary malignancy, except for adequately treated non-melanoma skin cancer.
- •Presence of significant comorbidities or medical conditions that may compromise the ability to undergo radiotherapy or participate in the study.
- •Contraindication to radiation.
研究组 & 干预措施
SBRT delivered with CBCT-guided online adaptive RT
Patients will undergo CT guided online adaptive SBRT 30-40Gy to the tumor nodal GTV volume(s) plus 25Gy in 5 fractions ENI to PA nodes (+/- pelvic nodes).
干预措施: Adaptive radiotherapy using SBRT (Radiation)
结局指标
主要结局
Quantify adverse events using CTCAE v5.0
时间窗: 2 years
Acute toxicities (≤3 months) and long-term toxicities (related to urinary, bowel or sexual function) will be collected and evaluated by the CTCAE v5.0.
次要结局
- QoL using EPIC questionnaire(2 years)
- Pain levels using EPIC questionnaire(2 years)
- Urinary function using EPIC questionnaire(2 years)
- Assessment of adaptive RT approach using dose accumulation(2 years)
- Bowel function using EPIC questionnaire(2 years)