Randomized Feasibility Trial of Prostate Radiotherapy vs Prostatectomy in Men With Hormone Sensitive Oligometastatic Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Patients willing to accept their randomization
研究概览
简要总结
Patients with hormone sensitive oligometastatic prostate cancer (≤ 5 metastatic tumours outside of regional pelvic nodes with no more than 3 in any organ system) and no previous treatment to prostate will be treated with intermittent androgen deprivation therapy +/- chemotherapy, stereotactic radiotherapy to all metastases, and either radical prostatectomy or radiotherapy.
详细描述
Investigators propose to do a randomized feasibility trial comparing RP vs RT to the prostate in the setting of hormone sensitive oligometastatic prostate cancer. SBRT will be used to treat all of the metastases, and this will be combined with an intermittent ADT approach. Adding systemic chemotherapy will be allowed. Given the past difficulties of randomizing patients between RP and RT in localized prostate cancer studies (like SPIRIT), investigators feel a small feasibility project is the first step. In the setting of metastatic disease, where radical treatment is not routine standard of care, we hope that patients will be more inclined to accept randomization. If patients do not accept their assigned randomization (ie they prefer RP even though they are randomized to RT, or vice versa), they will still be treated with their prostate intervention of choice and followed for their outcomes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent.
- •Histologic confirmation of prostate adenocarcinoma.
- •Stage IV disease with ≤ 5 metastases outside of the pelvis.
- •≤ 3 metastases in any one organ system.
- •ECOG performance 0-
- •All metastatic tumours amenable to SBRT.
- •Patient eligible for either RP or RT to the prostate.
排除标准
- •Castration resistant prostate cancer.
- •Previous RP or RT to prostate.
- •Inability to treat all metastases with SBRT.
- •Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, in-situ cancer, superficial bladder cancer, chronic lymphocytic leukemia or low grade lymphoma which is being observed.
研究组 & 干预措施
Arm 1
Radical prostatectomy
干预措施: Radical prostatectomy (Procedure)
Arm 2
Radiotherapy
干预措施: HDR (19Gy) or SBRT (35-40Gy) (Radiation)
结局指标
主要结局
Patients willing to accept their randomization
时间窗: 2 years
Patients willing to accept their randomization will be measured as a proportion.
次要结局
- Efficacy(7 years)
- Toxicity(7 years)
研究者
Dr. Patrick Cheung
Dr. Patrick Cheung
Sunnybrook Health Sciences Centre