NCT01856855已完成不适用
RAD 1203: Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer
John Fiveash, MD2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2013年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Number of Patients Who Experienced Early Toxicity of SBRT With Integrated Boost for Localized Prostate Cancer
研究概览
简要总结
This study will investigate the safety, tolerability, and effectiveness of giving a higher dose to the part of the prostate which contains the cancer while giving a standard radiation dose to the entire prostate. The investigators have hypothesized that this treatment technique will effectively control the prostate cancer while minimizing the side effects.
详细描述
Objectives:
Primary
-Clinically assess the early toxicity of SBRT with integrated boost for clinically localized prostate cancer
Secondary
- Determine the technical feasibility of stereotactic body radiotherapy (SBRT) with integrated boost for clinically localized prostate cancer
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All patients must have Histologically confirmed prostate adenocarcinoma, with biopsies obtained within twelve months of patient registration
- •NCCN risk category very low, low, or intermediate risk
- •Combined Gleason score <7
- •PSA within three months of enrollment < 20ng/ml
- •Clinical stage T1a-c N0M0 or clinical stage T2aN0M0
- •Life expectancy > 5 years
- •Risk of malignant lymph node involvement < 15% as calculated on Partin tables
- •Karnofsky performance status (KPS) > 60
- •Age > 19 years
- •Subjects given written informed consent
排除标准
- •History of inflammatory bowel disease
- •Prior radical prostate surgery, transurethral resection of the prostate(TURP), or prostate cryotherapy
- •Patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during SBRT course. Use of corticosteroids are not considered an exclusion criteria.
- •Platelet count < 70
- •Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin. Use of aspirin is not an exclusion criteria.
- •Pre-SBRT prostate volume > 120 cc as estimated by trans-rectal ultrasound at time of prostate biopsy (TRUS biopsy).
- •Risk of malignant lymph node involvement > 15% as calculated on Partin tables.
结局指标
主要结局
Number of Patients Who Experienced Early Toxicity of SBRT With Integrated Boost for Localized Prostate Cancer
时间窗: Within 3 months of the completion of radiation therapy
Early toxicity (defined as events occurring within 90 days of therapy) will be assessed by physician history and physical exams and patient toxicity/quality-of-life questionnaires to be administered at regular intervals.
次要结局
- Early Efficacy(Within 6 months of completion of radiation therapy)
- Number of Patients Who Experienced Late Toxicity(Within 6 months of completion of radiation therapy)
- Median Quality of Life Score(Within 6 months of completion of radiation therapy)
- Treatment Planning Feasibility(Within 6 months of completion of radiation therapy)
研究者
John Fiveash, MD
Professor and Vice Chair, University of Alabama at Birmingham Department of Radiation Oncology
University of Alabama at Birmingham
研究点 (2)
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