Prospective Evaluation of Cyberknife Stereotactic Radiosurgery for Low and Low/Intermediate Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 73
- 试验地点
- 8
- 主要终点
- Number of Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0
研究概览
简要总结
RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This trial is studying the side effects of stereotactic radiation therapy and to see how well it works in treating patients with prostate cancer.
详细描述
OBJECTIVES:
Primary
- To estimate in both low- and low-to-intermediate-risk groups of patients with prostate cancer, the rate of acute toxicities observed during the 5 years following CyberKnife® stereotactic radiosurgery (SRS).
Secondary
- To estimate the rate of late grade 3-5 toxicities after SRS in these patients.
- To measure biochemical disease-free survival of patients treated with this therapy.
- To measure rates of local failure, distant failure, disease-free survival, disease-specific survival, and overall survival of patients treated with this therapy.
- To measure quality of life in generic and organ-specific domains in patients treated with this therapy.
- To evaluate imaging modalities and their potential role in the detection of prostate cancer persistence, recurrence, and/or progression in patients treated with this therapy.
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
- — 至 120 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CyberKnife® stereotactic radiosurgery
干预措施: questionnaire administration (Other)
CyberKnife® stereotactic radiosurgery
干预措施: implanted fiducial-based imaging (Procedure)
CyberKnife® stereotactic radiosurgery
干预措施: stereotactic radiosurgery (Radiation)
结局指标
主要结局
Number of Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0
时间窗: Within 90 days of completing treatment
This study's primary goal is to determine the rate of acute grade 3-5 toxicities following CyberKnife treatment. Per RTOG/ECOG, acute toxicity will be defined as occurring within 90 days of completing treatment.
次要结局
- Disease-specific Survival(Assessed yearly for 5 years)
- Overall Survival(Assessed yearly for 5 years)
- Number of Late Grade 3-5 Toxicities as Assessed by NCI CTCAE v3.0(Within 5 years of completing treatment)
- Biochemical Disease-free Survival(Assessed at months 3,6,12,18,24 and every 6 months through 5 years)
- Disease-free Survival (Phoenix and ASTRO Definitions)(Assessed yearly for 5 years)
- Rate of Local Failure(Assessed at months 3,6,12,18,24 and every 12 months through 5 years)
- Quality of Life as Measured by the Short Form-12 Health Survey, Expanded Prostate Cancer Index Composite, and the American Urological Association Symptom Index, and the Utilization of Sexual Medications/Devices(Survey at 1,6,12 months and yearly up to 5 years)
- Rate of Distant Failure(Assessed at months 3,6,12,18,24 and every 12 months through 5 years)