PRAGMA (Prostate Radio Ablation Guided by Magnetic Resonance Imaging Acquisition) in Metastatic Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in Number of Subjects With Adverse Events Will be Collected
研究概览
简要总结
Patients with metastatic prostate cancer can undergo MRI-guided prostate Stereotactic body radiation therapy (SBRT) without significant adverse events, similar to what has been reported for patients with localized prostate cancer. We hypothesize that prostate SBRT will be well-tolerated in metastatic prostate cancer patients, with quality of life outcomes similar to what has been reported in non-metastatic prostate cancer patients.
详细描述
The MRidian ViewRay offers delivery of prostate SBRT with real-time MR guidance, which provides superior soft-tissue differentiation with excellent visualization of the prostate. This ViewRay platform offers the ideal setting for this study, that aims at precisely delivering prostate SBRT with a simultaneous integrated boost (when indicated) to visible nodules.
In this study, we hope to demonstrate the safety and feasibility of using 36.25 Gy in 5 fractions, plus a simultaneous integrated boost (when indicated), in patients with metastatic prostate cancer.
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 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven diagnosis of prostate adenocarcinoma
- •Must have biopsy-proven metastatic prostate cancer
排除标准
- •History of prior pelvic radiation (external beam or brachytherapy)
- •Inability to undergo MRI
- •AUA score >20
- •For patients on systemic therapy, enrollment must be within six months of start of therapy unless exception is made by protocol PIs.
结局指标
主要结局
Change in Number of Subjects With Adverse Events Will be Collected
时间窗: baseline, 3-6months and at 9-12 months.
Treatment will be deemed safe if there is no more than 3 acute Grade 3 gasterointestinal/genitourinary events within the first 30 days after treatment completion. Adverse events can be unexpected or expected, related to treatment.
次要结局
- Change in Quality of Life Questionnaires Will be Assessed.(baseline, 3-6months and at 9-12 months.)
- Change in The International Prostate Symptom Score (I-PSS) Will be Assessed.(baseline, 3-6months and at 9-12 months.)