Low Dose Supplemental External Radiation With PD-103 Versus PD-103 Alone For Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 396
- 试验地点
- 4
- 主要终点
- Serial PSA : 6, 12, 18 and 24 months and then yearly.
研究概览
简要总结
The primary purpose of this study is to evaluate two treatment regimens for prostate cancer, prostate implant with 20 Gy of external beam radiation therapy versus prostate implant with 0 Gy of external beam radiation therapy. Patients diagnosed with intermediate risk prostate cancer between the ages of 40 and 80 who have chosen brachytherapy with or without external beam radiation therapy as their intended treatment will be eligible and will be offered participation.
详细描述
Approximately 250,000 men are currently diagnosed with prostatic cancer in the United States each year. Of those, 70% have stage T1 or T2 disease (apparently limited to the prostate gland). Clinically localized prostate cancer is a spectrum of disease, ranging from good prognosis to poor prognosis. Patients with a PSA above 10 ng/ml or Gleason score of 7 to 10 are referred to as intermediate risk, with approximately an 80% chance of cure.
Implantation of radioactive sources directly into the prostate (brachytherapy) delivers a high, localized radiation dose while sparing most the of the bladder and rectum. Brachytherapy is well established for other tumor sites, and has become a standard treatment for prostate cancer.
Establishing that a good quality implant alone is as effective as implant plus beam radiation will allow us to routinely drop the use of beam radiation, a change in policy that will decrease the risk of some complications, will be more convenient for patients, and will lower treatment costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with previously untreated prostatic cancer.
- •Must have PSA 10-20 ng/ml, Gleason 7 to 9
排除标准
- •Patients with proven regional lymph node involvement will be excluded.
结局指标
主要结局
Serial PSA : 6, 12, 18 and 24 months and then yearly.
时间窗: 6, 12, 18 and 24 months and then yearly
Serial PSA : 6, 12, 18 and 24 months and then yearly.
PSA which is suggestive of residual tumor.
时间窗: as needed
PSA which is suggestive of residual tumor.
Post treatment biopsies in those with persistently elevated
时间窗: as needed
Post treatment biopsies in those with persistently elevated
次要结局
未报告次要终点
研究者
Gregory Merrick, M.D.
Medical Director
Schiffler Cancer Center