A Phase II Trial of High-Dose Pelvic Lymph Node IMRT( Intensity Modulated Radiation Therapy) and Hypofractionated Prostate IMRT for High Risk Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from baseline PSA level
研究概览
简要总结
The purpose of this study is to find out the effects (good and bad) of using newer technologies that allow very precise delivery of radiation. These newer technologies are Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).
详细描述
In this study the treating physicians will deliver a high dose of radiation to pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy). The study will evaluate the response of the cancer and side effects of radiation to pelvic lymph nodes and to the prostate.
It is hoped that these newer technologies will:
- allow a higher daily dose of radiation to the tumor and pelvic nodes
- avoid nearby normal tissue and organs like the rectum and bladder
- prevent the cancer from spreading or coming back
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
- •T1-2N0M0 with risk of pelvic lymph nodes involvement >25% by Roach formula [(2/3xPSA) + (Gleason Score - 6)x10], or any T3-4N0M0
- •Karnofsky Performance Scale >
- •Prostate tumor biopsy grading by Gleason score classification is mandatory prior to registration.
- •No prior pelvic or prostate radiation or chemotherapy for any reason; induction hormonal therapy prior to registration is acceptable.
- •Patients must sign a study-specific consent form prior to registration.
- •No evidence of distant metastases (Bone scanning)
排除标准
- •Clinical or pathological evidence of distant metastases (M1).
- •Radical surgery for carcinoma of the prostate
- •History of prior chemotherapy
- •History of prior pelvic radiation therapy
- •Children (age < 18).
研究组 & 干预措施
IMRT & IGRT Radiation Therapy
In this study we will deliver a high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy).
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Change from baseline PSA level
时间窗: 55 months
PSA level in blood is measured in units of nanograms per milliliter.
次要结局
未报告次要终点
研究者
William Hall
Professor
Medical College of Wisconsin