A Phase II Clinical Study of Stereotactic Radiation Therapy Based on Multiparameter Magnetic Resonance Image in Patients With High-risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- biochemical relapse-free survival
研究概览
简要总结
Stereotactic body radiotherapy (SBRT) has emerged as an effective and safe treatment for low and intermediate-risk prostate cancer(PCa). However, there is no study that has investigated the effectiveness and safety of SBRT with pelvic radiation and gross target volume(GTV) boost for high-risk prostate cancer patients yet. The investigators designed a phase II clinical study of SBRT with pelvic radiation and GTV boost based on mpMRI in patients with high-risk prostate cancer.
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 95 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •pathologically confirmed high-risk (T3a or Gleason score ≥ 8 or a PSA > 20 ng/ml) prostate cancer
- •a WHO performance status 0-1
- •history of neoadjuvant androgen deprivation therapy(ADT) within 6 months before enrollment
- •Patients with pelvic positive lymph node were also included in our study
排除标准
- •distant metastasis
- •history of neoadjuvant ADT over 6 months before enrollment
- •history of definitive treatment for prostate cancer such as radical prostatectomy
- •history of pelvic irradiation; prostate volume≥100 cm3
研究组 & 干预措施
stereotactic body radiotherapy
Long-term ADT of 2-3years were administered. Neoadjuvant ADT within 6 months was allowed.Then patients with high-risk prostate cancer recieve stereotactic body radiotherapy with pelvic radiation and GTV boost based on multiparameter magnetic resonance image.
干预措施: stereotactic body radiotherapy (Radiation)
结局指标
主要结局
biochemical relapse-free survival
时间窗: three months
2-years biochemical relapse-free survival
次要结局
- patient-reported quality of life(three months)
- the incidence rate of acute toxicity(every week)
- the incidence rate of late toxicity(three months)
- symptom score(three months)