NCT04212715招募中2 期
Prostate SABR With Intra-Prostatic SABR Boost: A Phase II Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Acute Toxicity
研究概览
简要总结
Stereotactic Ablative Radiation (SABR/SBRT) will be prescribed to a dose of 35 Gy in 5 fractions, once weekly to prostate with a simultaneous intra-prostatic boost to the MR detected nodule up to 50Gy. The pelvic lymph nodes and seminal vesicles will also receive 25 Gy in 5 weekly fractions.
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 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed prostate adenocarcinoma
- •High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA > 20 ng/mL
- •Willing to give informed consent to participate in this clinical trial
排除标准
- •Prior pelvic radiotherapy
- •Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
- •Contraindication to prostate MRI
- •No evidence of castrate resistance (defined as PSA < 3 ng/ml while testosterone is < 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
- •Definitive extrapelvic nodal or distant metastatic disease on staging investigations.
结局指标
主要结局
Acute Toxicity
时间窗: 3 month after accrual is completed
To document the rate of acute urinary and bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) criteria
次要结局
未报告次要终点
研究者
Dr. Yasir Alayed
Consultant and Assistant Professor
King Saud University
研究点 (1)
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