Phase I-II Trial of Hypofractionated Conformal Proton Beam Radiation Therapy for Favorable-risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 2
- 主要终点
- Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0
研究概览
简要总结
The purpose of this study is to determine hypofractionated conformal proton beam radiation therapy of prostate cancer can achieve similar treatment benefits as our current institutional standard with conventional fractionation.
详细描述
Radiation therapy has a long and established role in the curative treatment of organ-confined prostate cancer. However, the optimal radiation dose and treatment schedule remain unknown. The use of hypofractionation has a long and generally successful history in conformal proton beam therapy. Several reports detailing the efficacy and safety of hypofractionated conformal radiation therapy (with x-rays) of prostate cancer can be found in the literature. Hypofractionated conformal proton beam radiation therapy has become our institutional routine for the treatment of numerous solid tumors. The purpose of this study is to determine if a shortened overall treatment schedule will result in equivalent tumor control rates and no increased side effects as compared to our current institutional standard treatment of an equivalent dose given over a longer period of time.
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 within 180 days of registration
- •History & Physical Exam, including digital rectal exam (DRE), within 8 wks prior to registration
- •Histologic evaluation of prostate biopsies at LLUMC, with Gleason score assignment
- •Clinical stage, Tumor Stage (T1-T2C)
- •Prostatic Specific Antigen (PSA) less than 10 ng.ml within 180 days prior to registration
排除标准
- •Prior or concurrent invasive malignancy
- •Evidence of distant metastasis
结局指标
主要结局
Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0
时间窗: Every 6 months after completing treatment through the duration of the trial with a minimum of 2 years follow-up and an average of 5 years
To determine if late CTCAE version 4.0 Grade 3 treatment-related morbidity, which is no worse than that engendered by our current institutional standard with conventional fractionation, can be maintained in a hypofractionated schedule.
次要结局
- Number of Participants With Acute and Late Gastrointestinal or Genitourinary Grade 2 Morbidity, CTCAE Version 4.0(Every 6 months after completing treatment through the duration of the trial, with a minimum of 2 years follow-up and an average of 5 years)
研究者
Jerry D. Slater, MD
Professor and Chair Department of Radiation Medicine
Loma Linda University
