Comparison of Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Recurrence After Radical Prostatectomy (SHARE Trial): a Prospective, Randomized Controlled, Open-label, Multi Center, Superiority Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 288
- 试验地点
- 4
- 主要终点
- Biochemical recurrence-free survival
研究概览
简要总结
Patients with a biochemical recurrence after radical prostatectomy for moderate- or high- risk prostate cancer are randomly assigned to hypofractionated, accelerated high dose radiation therapy group (65 Gy, 26 fractions) and a control group of standard treatment group (66 Gy, 33 fractions). The criteria for stratification at randomization include 1) risk groups, 2) androgen deprivation therapy, and 3) PSA before salvage radiation therapy, which affect biochemical recurrence.
It is expected that hypofractionated, accelerated high dose radiation therapy will have a superiority in terms of biochemical control to conventional radiation therapy, and the present study would like to confirm this. In addition, we aimed to evaluate and compare the toxicity and quality of life index of two radiation therapy regimens.
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
- 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
- •Biochemical recurrence after radical prostatectomy (Definition: Serial elevation of PSA over 0.2 ng/mL and <=1.0 ng/mL)
- •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
- •Clinically gross recurrent tumor
- •Presence of distant metastasis
- •Presence of pelvic LN metastasis
- •History of pelvic irradiation
- •History of cryotherapy or brachytherapy for prostate cancer
- •Double primary cancer other than skin/thyroid cancer
- •Combined serious morbidity
结局指标
主要结局
Biochemical recurrence-free survival
时间窗: 5 years
PSA \>0.2 ng/mLfollowed by a repeat measurement \>0.2 ng/mL
次要结局
- Quality of life 1(the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years)
- Chronic toxicities(Adverse effects occured after 3 months since end of radiation therapy)
- Quality of life 2(the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years)
- Acute toxicities(Adverse effects occured during radiation therapy, and within 3 months after radiation therapy)
研究者
Young Seok Kim
Professor
Asan Medical Center