Hypofractionated Intensity Modulated Radiation Therapy Plus Hormonal Therapy in Patients With High Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Toxicity
研究概览
简要总结
Considering the promising results with hypofractionated in low and intermediate risk prostate cancer, our proposal is to translate this experience to patients with high risk prostate cancer. Patients with high risk disease would receive hypofractionated RT to the prostate and to the external and internal iliac lymph nodes using IMRT plus long-term hormonal therapy. The objective of the study is to show that long term grade>2 late toxicity is acceptable and similar to published data using hypofractionated technique in the prostate only.
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
- •pathologically proven diagnosis of adenocarcinoma of the prostate meeting one of the following conditions:
- •Clinical Stage >T3 or
- •Gleason Score 8 or higher, or
- •PSA level >20ng/ml
- •Study entry PSA must be obtained within 6 weeks prior to protocol entry
- •History and physical examination within 3 months
- •Bone scan and CT scan of the abdomen and pelvis within 3 months with no evidence of bone metastases and no pelvic lymph nodes larger than 1.0cm, unless biopsy negative.
- •CBC with differential within 6 weeks prior to protocol entry
- •Absolute neutrophil count >2000cells/mm3
- •Hemoglobin >8.0 g/dl (the use of transfusion to increase the Hg is acceptable)
- •Testosterone level within 6 weeks of protocol entry
- •Liver function tests
- •Signed informed consent
- •Prior use of hormonal therapy for prostate cancer is acceptable if less than 2 months.
排除标准
- •Prior use of hormonal therapy for prostate cancer for more than 2 months. Previous use of finasteride or dutasteride is allowed.
- •Prior invasive malignancy (except non-melanoma skin) unless disease-free for more than 5 years.
- •Prior radiotherapy to the pelvis
- •Life expectancy of less than 2 years.
结局指标
主要结局
Toxicity
时间窗: First 3 months (acute toxicity)
Acute and late toxicity following treatment with IMRT to the prostate and pelvic lymphatic chains will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (http://ctep.cancer.gov) for grading of all adverse events will be used in this study.
次要结局
- Freedom from biochemical failure, patterns of failure.(At 5 years)
研究者
Sergio Faria
Associate Professor. Oncology.
McGill University Health Centre/Research Institute of the McGill University Health Centre