VIRTUAL HDR CYBERKNIFE RADIOSURGERY FOR LOCALLY RECURRENT PROSTATIC CARCINOMA: A PHASE II STUDY
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Establish pattern of PSA decline
研究概览
简要总结
The purpose of this study is to scientifically evaluate the effects (good and bad) of a new type of radiation treatment in patients with locally recurrent prostate cancer after prior radiotherapy. The treatment is known as prostate radiosurgery, and is distinguished from traditional radiotherapy by the application of smaller, more precisely controlled margins around the area targeted for full dose radiation, and far fewer treatments, using a much larger dose per treatment.
This research is being done to see what advantages, if any, prostate radiosurgery may have over other salvage treatment methods, including brachytherapy, cryosurgery, high intensity focused ultrasound (HIFU), hormonal therapy and radical prostatectomy.
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
- •Histologically confirmed recurrent adenocarcinoma of the prostate, clinical stage T1 - T3 (AJCC 6th Edition, see Appendix II), NX/N0, M0, following prior prostate radiotherapy.
- •Karnofsky performance status >
- •Greater than 5 year life expectancy
- •Greater than 2 years since the original course of radiotherapy.
- •Absence of distant metastases by radiologic or pathologic assessment.
- •Absence of lymph node involvement by radiologic or pathologic assessment.
- •Patients must sign a study-specific informed consent form prior to study entry.
排除标准
- •Stage T4 disease (AJCC 6th Edition, see Appendix II).
- •Less than 2 years since the original course of radiotherapy.
- •Lymph node involvement (N1).
- •Evidence of distant metastases (M1).
- •Radical surgery for carcinoma of the prostate
- •Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years.
- •Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
- •History of inflammatory bowel disease
- •Late GI or GU Morbidity > Grade 1 from the prior course of radiotherapy
研究组 & 干预措施
CyberKnife Radiosurgery
Single arm study using CyberKnife radiosurgery to treat recurrent prostate cancer patients that have already received external beam radiotherapy.
干预措施: CyberKnife Radiosurgery (Radiation)
结局指标
主要结局
Establish pattern of PSA decline
时间窗: Post CyberKnife Radiosurgery - 5 year f/up
次要结局
- Quality of Life realitive to other commonly used radiation treatment methods for recurrent prostate cancer(Post CyberKnife Radiosurgery/5 yr. f/up)
研究者
Carlyn Tripp
Donald Fuller, M.D.
CyberKnife Centers of San Diego