NCT02339701进行中（未招募）不适用
A Randomized, Open Label, Phase II Study: Stereotactic Body Radiotherapy (SBRT) vs Conventional Intensity-modulated Radiotherapy (IMRT) for Low or Intermediate Risk Prostate Cancer in Asia Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- health-related quality of life (HRQOL)
研究概览
简要总结
The primary goal of this phase II study is to compare the change of EPIC HRQOL scores (1-year minus baseline) between SBRT and IMRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Histological confirmation of prostate adenocarcinoma
- •Low or intermediate risk prostate cancer patients (i.e. T1-T2c and PSA 20 and Gleason score < 8) with the risk of pelvic node metastasis 15% as calculated by Roach's formula
- •ECOG performance score 0-1
- •History/physical examination within 2 weeks prior to registration
- •Able to sign informed-consent
排除标准
- •Patients with previous diagnosis of cancer other than prostate cancer and non-melanoma skin cancer.
- •Evidence of distant metastases
- •Regional lymph node involvement
- •Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer
- •Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
- •Previous hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide) or LHRHantagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g.DES), or surgical castration (orchiectomy)
- •Unstable angina and/or congestive heart failure requiring hospitalization, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiringhospitalization or precluding study therapy at the time of registration
- •Patients who have received prior chemotherapy.
结局指标
主要结局
health-related quality of life (HRQOL)
时间窗: 1 year
次要结局
- the rate of acute and late GI and GU toxicity(5 years)
- disease-specific survival(5 years)
- biochemical-failure free survival(5 years)
- overall survival(5 years)
研究者
CCTU
Comprehensive Clinical Trial Unit
Chinese University of Hong Kong
研究点 (1)
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