Robotic Radiation Treatment of Prostate Cancer Patients Aged 70 y or More
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Acute and late toxicity (Using the CTCAEv4)
研究概览
简要总结
Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly.
Inclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA (Prostate Specific Antigen) <30ng/ml.
Dose : 36.25 Gy in 5 fractions, in 10 days, considering CAPRA Scores≤5 AND 37.5 Gy in 5 fractions, in 10 days, considering CAPRA Scores>5.
Primary objective : acute and late toxicity evaluation at 36 months. Secondary objectives : PSA and MRI response.
详细描述
Robotic Stereotactic Radiation treatment of prostatic adenocarcinoma of the elderly.
Rationale : Half of the prostatic adenocarcinoma are diagnosed in the elderly but until now curative treatments were not proven to increase overall survival rates. Therefore, very short, comfortable and safe treatments have to be designed to increase the pelvic control of the disease. Moreover, the alpha/beta ratio of the disease ≤3Gray is in favour of using hypofractionation schemes.
Primary objective : acute and late toxicity evaluation at 36 months. Secondary objectives : PSA and MRI response and quality of life evaluation.
Inclusion criteria : T1-T3b, MRI pelvic nodes negative, M0, any Gleason Score, PSA<30ng/ml.
Dose : 36.25 Gray in 5 fractions, in 10 days, considering CAPRA Score≤5 AND 37.5 Gray in 5 fractions, in 10 days, considering CAPRA Scores>5.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •MRI pelvic nodes negative,
- •any Gleason Score,
- •PSA<30ng/ml,
- •WHO (World Health Organisation) score<2, IPSS≤15,
- •maximal urinary flow rate ≥15ml/s,
- •mean urinary flow rate ≥5ml/s,
- •multiparametric prostatic and pelvis MRI
排除标准
- •Prostatic volume > 100cc,
- •TURP (transurethral prostatectomy) <3 y,
- •any recurrent prostatitis within the last 3 years,
- •collagenose diseases,
- •ulcero-haemorrhagic rectocolitis or
- •crohn diseases
结局指标
主要结局
Acute and late toxicity (Using the CTCAEv4)
时间窗: During 36 months after treatment
Using the CTCAEv4
次要结局
- Birads score evaluation(at 36 months)
- PSA evaluation(at 4 and 6 months, than every 6 months for 3 years)
- Digital rectal exam(at 6, 12, 24 and 36 months)
- IIEF5 evaluation(at 12, 24 and 36 months)
- IPSS evaluation(at 12, 24 and 36 months)