Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer - Ultra-HART
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Quality of Life (EPIC 26)
研究概览
简要总结
In this prospective, multi-center cohort study, the tolerability and quality of life during ultrahypofractionated radiotherapy (RT) of early stage prostate cancer is surveyed at several institutions in Germany. Radiotherapy is delivered by an online-adaptive RT device (Varian Ethos), which is able to correct daily variations in anatomy and to adjust the irradiation plan accordingly. A digital patient questionnaire is used to asses quality of life longitudinally. Quality of life (QoL) and toxicity profiles will be correlated with planning parameters and compared to retrospective cohorts of patients who underwent normofractionated RT or moderately hypofractionated RT, respectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •no androgen deprivation therapy within the last 2 months prior to RT
- •good performance status (Eastern Cooperative Oncology Group, ECOG, 0/1)
- •no secondary malignancy
排除标准
- 未提供
结局指标
主要结局
Quality of Life (EPIC 26)
时间窗: longitudinally: before + during RT and during follow up (5 years, at least bi-annually)
Expanded Prostate Cancer Index Composite 26 (questionnaire)
次要结局
- Toxicity (CTCAE v5.0)(longitudinally: before + during RT and during follow up (5 years, at least bi-annually))
- Planning parameters(for every fraction, total: 5x (1 week))
- Dose constraints(for every fraction, total: 5x (1 week))
- Conformity indices(for every fraction, total: 5x (1 week))
- Quality of adaptive planning(for every fraction, total: 5x (1 week))
- PSA-value(longitudinally: before + during RT and during follow up (5 years, at least bi-annually))
- Overall survival(5 Years)
- Recurrence free survival(5 Years)
研究者
Georg Wurschi
Principal Investigator
Jena University Hospital