Prospective Clinical Study Comparing Patient-reported Outcomes Measurements (PROMS) After Adaptive or Conventional Radiotherapy in Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Demonstration that adaptive radiotherapy in prostate cancer helps reduce radiotherapy-induced side effects (digestive, urinary, and general toxicity) using PROMS questionnaires.
研究概览
简要总结
This prospective clinical study compares patient-reported outcome measures (PROMs) after adaptive or conventional radiotherapy in prostate cancer. Adaptive radiotherapy (ART) aims to reduce uncertainties related to daily anatomical variations, thereby improving treatment accuracy while decreasing gastrointestinal (GI) and genitourinary (GU) toxicity. This study, conducted at Cliniques universitaires Saint-Luc (Brussels and Ottignies sites), analyzes and compares toxicities in patients treated with ART on Ethos and those treated with conventional radiotherapy on Halcyon.
The primary objective of the study is to demonstrate that ART reduces gastrointestinal, urinary, and general side effects induced by radiotherapy. Additionally, the secondary objectives include assessing the duration of these effects, correlating them with dosimetric data, analyzing the management of toxicities through the Noona e-health application, as well as evaluating the use of this application by both patients and healthcare providers.
The study includes men aged 18 years or older with prostate cancer undergoing curative-intent treatment, with an ECOG performance status of 0 to 1, and able to use the Noona application. Patients with a history of rectal or bladder treatment, or those who have already received pelvic radiotherapy, are excluded. Two groups are compared: patients treated with conventional radiotherapy on Halcyon (Ottignies site) and those treated with adaptive radiotherapy on Ethos (Brussels site).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients with prostate cancer referred for curative-intent radiotherapy
- •Male patients ≥ 18 years old
- •ECOG performance status 0-1
- •Patients willing to use an e-health application
- •Patients capable of using an e-health application
- •Proficient in French, English, or Dutch
- •No prior history of treatment for rectal or bladder cancer
- •No prior history of pelvic radiotherapy
排除标准
- •Cognitive impairment
- •History of treatment for rectal or bladder cancer
- •History of pelvic radiotherapy
- •No access to the Noona application on a smartphone or computer
研究组 & 干预措施
Arm H-RT
Treatment planned and delivered on the Halcyon machine with non-adaptive conventional radiotherapy.
干预措施: Radiotherapy (Radiation)
Arm E-ART
Treatment planned and delivered on the Ethos machine with adaptive radiotherapy.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Demonstration that adaptive radiotherapy in prostate cancer helps reduce radiotherapy-induced side effects (digestive, urinary, and general toxicity) using PROMS questionnaires.
时间窗: 3 years
In this clinical study, we aim to demonstrate that adaptive radiotherapy (ART) in prostate cancer can reduce radiotherapy-induced side effects (digestive, urinary, and general toxicity). Daily adaptation of treatment plans not only ensures better target coverage but also accounts for daily variations in the position or deformation of organs at risk (OARs). Consequently, ART could reduce the occurrence of genitourinary (GU) and gastrointestinal (GI) side effects, either early (during or shortly after treatment) or at later stages (up to one year after completion of treatment). Three questionnaires will be used: the Expanded Prostate Cancer Index Composite-26 (EPIC-26), the EuroQol 5 Dimensions (EQ-5D) and the International Prostate Symptom Score (IPSS).
次要结局
- Evaluation of the time to recovery from treatment-related adverse effects using PROMS questionnaires.(3 years)
- Correlation of the duration of adverse effects collected with PROMS questionnaire with the dosimetric data.(3 years)
- Evaluation of the management of treatment-related toxicity using the e-health application using a PREM questionnaire at the end of the study.(3 years)
- Number of participants and medical staff satisfied by the ease of use of an e-health application during radiotherapy using a questionnaire.(3 years)