Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Men With Intermediate- or High-risk Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Acute toxicity assessment for 18 Gy and 21 Gy arm
研究概览
简要总结
For the treatment for intermediate- and high-risk prostate cancer, Cyberknife boost will be used after 4 weeks of intensity modulated radiotherapy to pelvis. The boost doses are 18 Gy and 21 Gy in 3 fractions, respectively. The investigators plan to evaluate the toxicity of two dose groups and decide the appropriate dose for Cyberknife boost. Also, PSA control will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed intermediate- or high-risk prostate cancer within 6 months after enrollment
- •ECOG performance status 0-1
- •Appropriate values of blood tests within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 Platelets ≥ 50,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl
- •Appropriate values of kidney function within 6 months after enrollment Creatinine < 2.0 ng/dL
- •Appropriate values of liver function within 6 months after enrollment total bilirubin < 1.5 X maximum normal value alanine aminotransferase or aspartate aminotransferase < 2.5 X maximum normal value
排除标准
- •Presence of distant metastasis
- •Presence of pelvic LN metastasis
- •History of androgen deprivation therapy within 6 months after enrollment
- •History of definitive treatment for prostate cancer (e.g., radical prostatectomy)
- •History of pelvic irradiation
- •Double primary cancer other than skin/thyroid cancer
研究组 & 干预措施
CK 18 Gy
Patients who receive Cyberknife boost dose of 18 Gy in 3 fractions
干预措施: Cyberknife boost 18 Gy (Radiation)
CK 21 Gy
Patients who receive Cyberknife boost dose of 21 Gy in 3 fractions
干预措施: Cyberknife boost 21 Gy (Radiation)
结局指标
主要结局
Acute toxicity assessment for 18 Gy and 21 Gy arm
时间窗: 3 months
CTCAE v4.03, overactive bladder symptom score (OABSS), International Prostate Symptom Score (IPSS)
次要结局
- Biochemical control free survival(3 years)
- Late toxicity assessment for 18 Gy and 21 Gy arm(average 6 months)
研究者
Young Seok Kim
Associate professor
Asan Medical Center