Safety and Early Efficacy of Radical Prostatectomy for Newly Diagnosed Very High Risk Locally Advanced and Oligometastatic Prostate Cancer - a Prospective Single Center Phase I/II Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The rate of perioperative complications within 90 days after surgery (Clavien-Dindo-classification)
研究概览
简要总结
Prostate cancer is the most common non-skin cancer diagnosed among men and the second leading cause of male cancer deaths in the United States. In 2013, it is estimated that 29,270 men have died from prostate cancer. Although radiation and surgery are quite effective for localized disease, there is no effective cure for men who present with metastatic prostate cancer as the 5-year relative survival rate is only 28%.
Currently, androgen deprivation therapy (ADT) via medical or surgical castration is the standard first-line therapy in men with metastatic disease but castration-recurrent prostate cancer (CRPC) eventually emerges with a median time of 18-24 months. Once CRPC develops, secondary hormonal manipulation, chemotherapy, and immunotherapy are marginally effective.
Given the dismal prognosis of metastatic prostate cancer, new ideas and novel approaches must be explored to improve the clinical outcome. In this regard, recently emerging data suggest that local tumor control may enhance the effectiveness of subsequent systemic therapies. Therefore, in this proposal, the investigators have designed a Phase I/II study in which they will prospectively evaluate the safety and feasibility of cytoreductive prostatectomy in men with newly diagnosed mPCa.
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 75 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adenocarcinoma of the prostate
- •Very high risk PCA (PSA ≥ 20 oder Gleason Score ≥ 8 oder ≥ cT3) and/or oligometastasierte PCA (T any N positive M any, oder T any N any M positive)
- •≤5 bone metastasis
- •≤75 years
- •Ability for informed consent
- •Clinically no infiltration into the rectum or pelvic wall
- •Clinically no visceral metastasis
- •Male, >18 Jahre
- •Fit for surgery
- •ECOG Performance Status 0 oder 1
排除标准
- •Male, < 18 Jahre
- •> 5 bone metastasis
- •> 75 years
- •No ability for informed consent
- •Clinically infiltration into the rectum or pelvic wall
- •Not fit for surgery
- •Clinically visceral metastasis
结局指标
主要结局
The rate of perioperative complications within 90 days after surgery (Clavien-Dindo-classification)
时间窗: 90
次要结局
- Time to start androgen deprivation therapy(2 years)
研究者
Dr. Bernhard Grubmüller
MD
Medical University of Vienna
