NCT01505075Unknown1 期
Phase II Study of Dose-escalated, Hypofractionated Radiotherapy and Androgen Deprivation Therapy for High-Risk Prostate Cancer
适应症
试验速览
- 阶段
- 1 期
- 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 (40Gy/5 fractions/29 days) for the treatment of high risk prostate cancer currently being managed with primary androgen deprivation therapy (PADT).
详细描述
Primary Endpoints:
- Acute gastrointestinal (GI) and genitourinary (GU) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 toxicities
Secondary Endpoints:
- Late GI and GU Radiation Therapy Oncology Group (RTOG) toxicities
- Biochemical disease-free survival
- Biopsy positive rate at 3 years
- Quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
- Develop a biobank of DNA and serum extracted from blood and urine to analyze and develop new biomarkers for prostate cancer progression or susceptibility to severe toxicity
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
- •informed consent obtained
- •men > 18 years
- •histologically confirmed prostate adenocarcinoma (centrally reviewed)
- •high risk prostate cancer, defined as at least one of: clinical stage T3, or gleason score 8-10, or PSA > 20ng/mL
排除标准
- •prior pelvic radiotherapy
- •anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- •diagnosis of bleeding diathesis
- •pelvic girth > 40cm (to ensure visibility of gold seeds on electronic portal imaging)
- •large prostate (> 90cm3) on imaging
- •severe lower urinary tract symptoms (International Prostate Symptom Score >19 or nocturia > 3)
- •No evidence of castrate resistance (defined as PSA < 3ng/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
结局指标
主要结局
Incidence of grade 3+ rectal toxicity
时间窗: Acute period (up to 3 months)
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
次要结局
- Incidence of grade 3+ rectal toxicity(Late (after 6 months of follow-up))
- Incidence of grade 3+ urinary toxicity(Acute (up to 3 months) and Late (after 6 months of follow-up))
- Quality of Life(5 years)
- Biochemical (ie.prostate specific antigen) disease free survival(5 years)
研究者
研究点 (2)
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