跳至主要内容
临床试验/NCT04245670
NCT04245670进行中(未招募)不适用

5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:A Phase II Study (5STAR-PC)

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
75
试验地点
2
主要终点
Acute Toxicity

研究概览

简要总结

Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.

5-fraction SABR is a feasible, well-tolerated, effective and cost effective treatment for high-intermediate and high risk prostate cancer with/without an image-guided intraprostatic boost.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Acute Toxicity

时间窗: Baseline to 3 months post completion of treatment

To document the acute urinary toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria

次要结局

  • Economic analysis(Baseline to end of 5 year follow up)
  • Quality of Life outcome(Baseline to end of 5 year follow up)
  • Biochemical disease-free survival(Baseline to end of 5 year follow up)
  • Quality of life outcome(Baseline to end of 5 year follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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