Feasibility Trial of Individualized Daily Dose Adaptation for Localized Prostate Cancer by Online MR-guided SBRT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 主要终点
- Feasibility of online MR-guided SBRT: Number of fractions
研究概览
简要总结
The purpose of this study is to evaluate a technical feasibility of MR-guided SBRT fraction dose adaptation for low-risk, intermediate-risk and low-volume metastatic prostate cancer. .
详细描述
Hypofractionated SBRT to 36.25 Gy in 5 fractions (fraction dose 7.25 Gy) for low- and intermediate risk prostate cancer is standard of care. Using higher fraction doses that might be beneficial for disease control is not safe in all patients, unless adaptive treatment is performed. In this clinical trial the feasibility of online MR-guided SBRT fraction dose adaptation (between 7 and 8 Gy) for prostate cancer will be investigated. A fraction dose to the planning target volume (PTV) will be adapted to organs-at-risk (OAR) geometry (position, shape and volume) on online planning MRI scans of the treatment day ("geometry-of-the-day"). Thus the investigators hope to maximize treatment individualization.
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
- •Written informed consent according to Swiss law and ICH/GCP regulations before any trial specific procedures;
- •Histologically confirmed adenocarcinoma of the prostate;
- •Low (Grade group 1 [Gleason score ≤6], clinical stage T1-2a N0 M0, and PSA < 10 ng/ml) and intermediate (Grade group 2-3 [Gleason score 7], clinical stage T2b-2c N0 M0, PSA 10-20 ng/ml) risk prostate cancer with indications for SBRT with curative intent;
- •Newly diagnosed low-volume metastatic prostate cancer with indications for SBRT, in whom metastatic disease was confirmed on a bone scintigraphic scan and soft-tissue imaging done within 3 months of starting androgen deprivation therapy (ADT);
- •IPSS <15;
- •Age: ≥ 18 years old;
- •Karnofsky performance status ≥70;
- •Patients able to tolerate long (approximately 60 minutes) treatment time;
- •Patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures.
排除标准
- •Previous radical treatment for prostate cancer - either radiation therapy (external or brachytherapy), surgery, TUR-P, cryosurgery, or HIFU;
- •Contraindications for MRI, e.g., patients with metal fragments or implanted devices that are not MR compatible such as certain types of pacemakers and aneurysm clips or severe claustrophobia;
- •Lack of safe contraception;
- •Known or suspected non-compliance, drug or alcohol abuse;
- •Inability to follow the procedures of the trial, e.g. due to language problems of the participant;
- •Enrolment of the investigator, his/her family members, employees and other dependent persons.
结局指标
主要结局
Feasibility of online MR-guided SBRT: Number of fractions
时间窗: At the treatment end (treatment duration 2 weeks)
Number of fractions when a new online plan on the new patient geometry was successfully generated and applied according to the dosimetric protocol requirements
次要结局
- Quantifying intrafraction motion of the prostate (in mm) and organs-at-risk (in mm)(During each treatment session (treatment duration of 2 weeks))
- Quality of the adapted treatment plan vs. the initial treatment plan(At the treatment end (treatment duration 2 weeks))
- Rates of adverse events(weekly during treatment and up to 3 months after the treatment end)
- Duration of an online adaptive procedure(Before each treatment session (treatment duration 2 weeks))
- Quantifying interfraction motion of the prostate (in mm) and organs-at-risk (in mm)(Before each treatment session (treatment duration of 2 weeks))