Phase II Study to Evaluate the Efficacy of Intensity Modulated Radiation Therapy With Hypofractionated Radiosurgical Boosts in the Treatment of Clinically Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 主要终点
- Local failure
研究概览
简要总结
This phase II study designed to prospectively evaluate the efficacy and morbidity of IMRT with CyberKnife radiosurgical boosts for clinically localized prostate cancer. Patients will be treated with three radiosurgical treatments (6.5 Gy per fraction) followed by IMRT (45 Gy in 25 fractions).
详细描述
This is a phase II study designed to prospectively evaluate the efficacy and morbidity of IMRT with CyberKnife radiosurgical boosts for clinically localized prostate cancer. Patients with clinically localized prostate cancer will be treated with three radiosurgical treatments (6.5 Gy per fraction to the PTV) followed by IMRT (45 Gy in 25 fractions). Treatment will be completed over a 6-7 week period.
The hypothesis is that for patients with clinically localized adenocarcinoma of the prostate, CyberKnife Radiosurgery delivered to the prostate is efficacious with acceptable toxicity in combination with IMRT.
Subjects will have toxicity evaluation and AUA score on the last day of treatment. At 1 month following treatment, subjects 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), subjects will be seen and evaluated, including a history, physical exam, 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. 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. A bone scan will be performed at the time of biochemical failure, or when the subject develops signs of symptoms suggesting metastatic disease.
Acute side effects (≤ 90 days of treatment start) will be assessed using the NCI Toxicity Criteria version 3.0.
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 adenocarcinoma of the prostate (Biopsy within one year of enrollment)
- •Signed Study-Specific COnsent
- •PSA within 60 days of registration
- •Baseline AUA score is less than 20
排除标准
- •Prior Pelvic radiotherapy
- •Prior Radical Prostate surgery
- •Recent (within 5 years) or concurrent cancers other than non-melanoma skin cancer
- •Medical or psychiatric illness that would interfere with treatment or follow-up
- •Implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and/or treatment delivery.
结局指标
主要结局
Local failure
时间窗: 2 years after radiotherapy.
To estimate the rate of local failure as assessed by 2 year post-radiotherapy prostate biopsies. (Studies with the CyberKnife radiosurgery would be worthwhile for prostate cancer patients if the rate of local control was \> 70%)
次要结局
- Patient Reported Quality of Life: Expanded Prostate Cancer Index Composite-26 (EPIC-26)(During the 5 years following radiotherapy)
- Patient Reported Quality of Life: Sexual Health Inventory for Men (SHIM)(During the 5 years following radiotherapy)
- Biochemical disease-free survival (bDFS)(2 years after radiotherapy)
- Patient Reported Quality of Life: American Urological Association symptom index(During the 5 years following radiotherapy)
- Gastrointestinal and genitourinary toxicity(During 5 years following the CyberKnife SRS treatment for prostate cancer)
- Patient Reported Quality of Life: Utilization of Sexual Medications and Devices(During the 5 years following radiotherapy)
研究者
Sean Collins, M.D., PhD
Assistant Professor
Georgetown University