Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Biochemical Control Rate
研究概览
简要总结
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of organ confined prostate cancer.
详细描述
This is a single site, non-randomized, prospective, phase IV trial of patients with organ-confined prostate cancer. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues,tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.
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
- •Patient age >= 18 years
- •Zubrod performance status of 0-3
- •T1-3 N0 M0 adenocarcinoma of the prostate
- •Prostate volume ≤ 100 cc
- •Signed study-specific consent form
- •Exclusion Criteria
- •Extension of local tumor to involve adjacent organs other than seminal vesicles (T4)
- •Prostate volume > 100 cc
- •Nodal involvement
- •Metastatic disease
- •Prior pelvic radiotherapy except as part of combination therapy for prostate cancer
- •History of scleroderma
- •Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
排除标准
- 未提供
结局指标
主要结局
Biochemical Control Rate
时间窗: one year
Serial blood tests for prostate specific antigen (PSA) levels will be obtained at regular intervals (every 3 months).The "Phoenix definition" for biochemical recurrence (nadir + 2 ng/ml) will be used. Biochemical control rate will be expressed based on subjects experiencing tumor control (complete, partial, or stable) vs. subjects experiencing disease progression.
次要结局
- Late Toxicity Rate(one year)
研究者
Jaymeson Stroud, MD
Radiation Oncologist
Mercy Research