Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating Homogenous Dose Distribution
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Local control rate
研究概览
简要总结
The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage prostate cancer.
The investigators hypothesize that hypofractionated stereotactic radiotherapy via the CyberKnife® can deliver tumor ablating doses of radiation to prostate tumors safely and effectively while sparing the adjacent tissues (rectum, bladder, ureters, urethra, penile bulb, and bowel) from receiving damaging doses of radiation.
详细描述
The CyberKnife system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays (radiation) on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male Age ≥ 21
- •Histologically proven prostate adenocarcinoma
- •Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)
- •PSA ≤ 20 ng/ml
- •Prostate volume ≤ 100 cc
- •Patients belonging in one of the following risk groups:
- •CS T1b-T2a and Gleason 2-6 and PSA ≤ 10
- •Intermediate:
- •CS T2b and Gleason 2-6 and PSA ≤ 10, OR
- •CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml OR Gleason 7 and PSA ≤ 10 ng/ml
排除标准
- •Any histology other than adenocarcinoma
- •Age < 21
- •KPS <= 40 <70
- •ECOG Performance Status ≥ 2
- •Patient weight >350 lbs. (table limitation)
- •Prior XRT to prostate or lower pelvis
- •Prior surgery or cryotherapy to prostate
- •Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
- •Chemotherapy for a malignancy in the last 5 years
- •History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years
- •Hormone ablation for 2 months prior to enrollment, or during treatment
研究组 & 干预措施
CyberKnife Radiosurgery
干预措施: CyberKnife Radiosurgery (Radiation)
结局指标
主要结局
Local control rate
时间窗: 5-10 years
* To assess the effects of hypofractionated stereotactic radiosurgery on the long-term local tumor control of prostate cancer (through documentation of the rate of biochemical Disease-Free Survival \[bDFS\], Phoenix and ASTRO definitions, at 5 and 10 years). * To document the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity observed during the years following CyberKnife SRS for prostate cancer.
次要结局
- Overall survival(5-10 years)