A Phase I-II Prospective Trial of Conformal Hypofractionated Intensity Modulated Radiotherapy (IMRT) for Localized Adenocarcinoma of the Prostate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 2
- 主要终点
- To determine feasibility and late toxicity of administering 66 Gy in 22 fractions over 4.5 weeks (using conformal IMRT treatment techniques) to the prostate and adjacent tissues in patients with localized prostate ca
研究概览
简要总结
There are several different treatment schedules being used across the world for treatment of prostate cancer with radiation therapy. In order to determine the best radiation treatment for this disease, a study is being performed by the doctors at the Princess Margaret Hospital. This study will try to measure the effectiveness and side effects of an increased dose of radiation to the prostate that is also given over a shorter number of weeks than is usually done. In order to try to reduce the possible side effects of the radiation therapy the treatment will be given using special techniques to shield as much of your normal body tissues as possible. This method of treatment is called conformal intensity modulated radiation therapy, or IMRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of adenocarcinoma of the prostate within six months of entry
- •Clinical stage T1B, T1C, T2A-C NX MO (see Appendix 1 for staging). Any Gleason score is eligible for entry, but Gleason score must be determined.
- •Patients with a PSA >10.0 and Gleason score of 7; or patients with any PSA value and Gleason score of >8 must have clinically negative lymph nodes as determined by a pelvic CT scan done within 12 weeks of entry. A negative bone scan is required before entry for all patients with Gleason score >8, or any patient with a Gleason score of 7, and a PSA >
- •The patient must not have received any cytotoxic anticancer therapy. Previous or concurrent hormonal therapy for local disease is acceptable.
- •ECOG performance status of 1 or less
- •Age 80 years old or less
- •Serum PSA <25 ng/ml within 4 weeks of study entry
- •Informed consent
排除标准
- •Patients with history of inflammatory bowel disease or other contraindication to radical radiation therapy
- •Patients with prior colorectal surgery
- •Any prior pelvic radiotherapy. Any prior TURP done <12 weeks from study entry.
- •Any previous cytotoxic chemotherapy
- •Patients with prior malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of prostate cancer
研究组 & 干预措施
Conformal intensity modulated radiotherapy (IMRT)
All patients shall receive a continuous course of intensity modulated conformal radiotherapy consisting of 66 Gy in 22 (3 Gy) fractions over 4.5 weeks.
干预措施: conformal intensity modulated radiotherapy (IMRT) (Procedure)
结局指标
主要结局
To determine feasibility and late toxicity of administering 66 Gy in 22 fractions over 4.5 weeks (using conformal IMRT treatment techniques) to the prostate and adjacent tissues in patients with localized prostate ca
时间窗: at each post treatment follow-up for up to 3 years
次要结局
- To evaluate local control as assessed by prostate biopsy at 2.5 years(2.5 years)
- To evaluate time to disease progression(5 years)
- To evaluate acute toxicity of therapy(weekly during RT)