Phase II Study of Stereotactic Ablative Radiotherapy Including Regional Lymph Node Irradiation for Patients With High Risk Prostate Cancer (SATURN)
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Acute GU and GI toxicities
研究概览
简要总结
Current treatment options for high risk localized prostate cancer include radical prostatectomy +/- postoperative radiotherapy, radical radiotherapy with androgen deprivation therapy. Evidence has emerged that prostate cancer has a low α/β ratio in the range of 1-3 Gy. Even with high risk tumors, prostate cancer is hypothesized to have a greater sensitivity to large fraction sizes and high dose per fraction radiotherapy theoretically allows for biological dose escalation with fewer visits and no additional toxicity. Therefore, we hope to determine the toxicity, quality of life, biochemical and pathological control of SBRT for high risk prostate cancer incorporating ENI.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •informed consent obtained
- •men > 18 years of age
- •histologically confirmed prostate adenocarcinoma (centrally reviewed)
- •high risk prostate cancer, defined as at least one of clinical stage T3 or Gleason 8-10, or PSA > 20ng/mL
排除标准
- •prior pelvic radiotherapy
- •anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- •diagnosis of bleeding diathesis
- •large prostate (>90cm3) on imaging at time of gold seed insertion
- •no evidence of castrate resistance (defined as PSA < 3ng/mL while testosterone is < 0.7nmol/L
- •definitive regional or distant metastatic disease on staging investigations
结局指标
主要结局
Acute GU and GI toxicities
时间窗: Baseline to 3 months post treatment
Acute GU and GI toxicities as assessed using the Common Terminology for Adverse Events (CTCAE) v3.0
次要结局
- Quality of Life (QoL)(5 years)
- Disease free survival(2 years)
- Biochemical control(5 years)
- Late GU and GI toxicities(> 6 months post treatment)
研究者
Andrew Loblaw
Dr. Andrew Loblaw
Sunnybrook Health Sciences Centre