NCT01146340已完成1 期
Phase I/II Study of Dose-Escalated Hypofractionated Radiotherapy for Low- and Intermediate-Risk Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Incidence of grade 3+ rectal toxicity
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40 Gy / 5 fractions / 29 days) for the treatment of low- and intermediate-risk 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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men >18 years
- •Histologically confirmed prostate adenocarcinoma
- •Low or low-intermediate risk prostate cancer, defined as Clinical stage T1-2b, Gleason Score <=6, and PSA <15 ng/mL, OR Clinical stage T1-2b, Gleason Score 7, and PSA <=10 ng/mL
排除标准
- •Prior pelvic radiotherapy
- •Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- •Diagnosis of bleeding diathesis
- •Presence of a hip prosthesis
- •Pelvic girth >40cm - Large prostate (>90cm3) on imaging
- •Severe lower urinary tract symptoms (International Prostate Symptom Score >19 or nocturia >3)
研究组 & 干预措施
SBRT
Experimental
SBRT 40 Gy in 5 fractions over 29 days delivered using step and shoot IGRT
干预措施: Hypofractionated radiotherapy (Radiation)
结局指标
主要结局
Incidence of grade 3+ rectal toxicity
时间窗: Acute period (<3 months)
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
次要结局
- Quality of Life(5 years)
- Incidence of grade 3+ rectal toxicity(Late (>6 months))
- Incidence of grade 3+ urinary toxicity(Acute (<3 months) and Late (>6 months))
- Biochemical (ie. prostate specific antigen) disease free survival(5 year)
研究者
Andrew Loblaw
Radiation Oncologist
Sunnybrook Health Sciences Centre
研究点 (2)
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