NCT04997252招募中不适用
An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer
Zhujiang Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- rPFS
研究概览
简要总结
The neoadjuvant therapy with apalutamide can significantly improve the prognosis of patients with high-risk and oligometastatic prostate cancer, lower the rate of positive margins, reduce recurrence, and show high safety.
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
- •Adult males aged above 18 years old, no healthy volunteers included;
- •Prostate cancer confirmed by pathological findings;
- •High risk based on risk assessment, or laboratory tests suggestive of oligometastasis;
- •Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy;
- •ECOG score of 0 - 1
- •Agreement to undergo preoperative and postoperative endocrine therapy;
- •Voluntary signing of an ICF for the clinical trial
排除标准
- •Any other tumor disease requiring treatment;
- •Any organ metastasis confirmed by imaging, such as liver and brain metastases, or the possibility of paralysis due to spinal cord metastasis;
- •A history of epilepsy or any condition that may lead to seizures;
- •Severe liver or kidney dysfunction, severe cardiovascular or cerebrovascular diseases, and systemic immune system diseases.
研究组 & 干预措施
high-risk and oligometastatic prostate cance
Experimental
Neoadjuvant therapy with apalutamide in combination with luteinizing hormone-releasing hormone analogues
干预措施: Apalutamide (Drug)
结局指标
主要结局
rPFS
时间窗: Change from Baseline at preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
radiographic progression-free survival
次要结局
- pCR(preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.)
- PFS(preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.)
- PSA response rate:(preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.)
- TTPP(preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.)
- time to BCR after surgery(preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.)
- pathological stage(preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.)
研究者
Binshen Chen
associate chief physician
Zhujiang Hospital
研究点 (1)
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