Phase 2 Study of High Risk Prostatae Cancer Treated With Dose-escalated Simultaneous Integrated Boost to Prostate and Lymph Node GTV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- PSA progression free survival
研究概览
简要总结
A single arm phase 2 study to study the outcome of dose-escalation with simultaneous integrated boost to intraprostatic lesion and positive lymph nodes. Prostate cancer patients with high risk of lymph node metastasis or oligo positive nodes in true pelvic area can be included. The boost volumes will be outlined by usin PET-CT and MRI data. Our hypothesis is that we will have fewer relapses in this very high risk patient group compared to matched historical controls with acceptable side effects.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed high risk prostate cancer with a risk of lymphatic spread >15% according to the MSKCC nomogram (1) http://nomograms.mskcc.org/Prostate/PreTreatment.aspx
- •Written informed consent
- •> 18 years
- •Fiducial gold markers implanted in the prostate (min 3)
排除标准
- •• Non MR-safe implants or other contraindication to MRI
- •WHO PS>1
- •Previous pelvic irradiation
- •TURP within 6 months
- •IPSS >19
- •Metastatic disease in skeleton, parenchymal organs or lymph nodes outside the pelvis
- •Creatinin clearance < 30ml/min according to http://www.fass.se/LIF/produktfakta/kreatinin.jsp
结局指标
主要结局
PSA progression free survival
时间窗: 36 months
PSA progression defined according to American Society for Therapeutic Radiology and Oncology (ASTRO) Phoenix definition: nadir PSA + 2 ng/mL (on three consecutive measurements with at least one month between each)
次要结局
- Genitourinary Quality of Life(0 6 12 36 60 months)
- Gastrointestinal Quality of Life(0 6 12 36 60 months)
- Sexual Quality of Life(0 6 12 36 60 months)
- Overall Quality of Life(0 6 12 36 60 months)
研究者
Camilla Thellenberg Karlsson
MD, PhD
Umeå University