Prospective Evaluation of Truebeam STX Stereotactic Body Radiosurgery for Low and Intermediate Risk Prostate Cancer
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- acute and late GI/GU toxicity rate following treatment
研究概览
简要总结
The primary safety purpose of this study is to estimate the rates of immediate and long-term high grade (grade 3-5) gastrointestinal and genitourinary side effects during the five years after TrueBeam stereotactic body radiotherapy in low-risk and intermediate-risk prostate cancer patients. The primary efficacy purpose is to compare 5 year biochemical disease free survival rates with TrueBeam to 5 year biochemical diseases free survival rates with dose-escalated external beam radiation therapy.
详细描述
The prescribed PTV dose of 36.25Gy shall be given in 5 fractions using the Truebeam STx.
At one week after treatment, toxicity and AUA score will be evaluated. At 1 month following treatment, patients will be assessed for acute toxicity, and will fill out AUA form, SF-12, EPIC-26, SHIM and Utilization of Sexual Rx/Devices. At 3, 6, 12, 18, and 24 month intervals (and every 6 months thereafter, through year 5, and annually through year 10, if investigators opt to continue past year 5), patients will be seen and evaluated, including a history, physical exam, ECOG performance status, PSA, toxicity evaluation, and AUA score. In addition, at 6 months, 12 months and annually thereafter, the SF-12, EPIC-26, SHIM and Utilization of Sexual Medications/Devices will be administered. Examination and studies may be done at outside facility.
A prostate biopsy will be performed at time of biochemical or local clinical failure, and is encouraged at 2 years following treatment and at time of distant failure.
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
- •* histologically proven prostate adenocarcinoma within 1 year of enrollment
- •* Low risk: Gleason \ 10 \& \< or =20 \& Clinical Stage T1b- T2b, Nx or NO, Mx or M0
- •* ECOG Performance Status 0-1
- •* No prior prostate radiation or other definitive therapy
排除标准
- •implanted hardware or other material that would prohibit treatment planning or delivery
- •chemotherapy for a malignancy within the previous 5 years
- •history of an invasive malignancy (other than this prostate cancer,or basal or squamous skin cancers) within prior 5 years
- •hormone ablation for 2 months prior to treatment or during treatment
结局指标
主要结局
acute and late GI/GU toxicity rate following treatment
时间窗: 5 years
The study is designed to test the null hypothesis that the acute and late GI/GU toxicity rate 5 years following treatment is greater than 10% versus the alternative hypothesis that the toxicity rate is less than or equal to 10%. The sample size is determined such that there is 90% probability, or power, of identifying excessive toxicity if the true toxicity rate is 20% at the one-sided 5% significance level.
次要结局
- a comparison of biochemical disease free survival in low risk patients treated with TrueBeam compared to (historical) biochemical disease free survival in patients treated with dose-escalated external beam radiation therapy(5 years)
研究者
Albert DeNittis
Chief, Radiation Oncology. Lankenau Medical Center, Main Line Health
Main Line Health