NCT05740488招募中不适用
Efficacy and Safety of Apalutamide in Combination With 89Sr as Neoadjuvant Therapy in Prostate Cancer With ≤10 Bone Metastases
Zhujiang Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年1月7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
- 30
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of apalutamide in combination with 89Sr as neoadjuvant therapy in prostate cancer with ≤10 bone metastases. The primary endpoint is PFS and the second endpoints are pCR, rPFS, PSA response, pain score, number and extent of bone metastases.
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
- •Prostate cancer confirmed by pathological findings;
- •Bone metastasis confirmed by bone scan, the number of bone metastases ≤10
- •Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy;
- •ECOG score of 0 - 1
- •Agreement to undergo preoperative and postoperative endocrine therapy and 89Sr radionuclide 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
apalutamide combined with 89Sr and ADT
Experimental
Neoadjuvant therapy with apalutamide in combination with 89Sr and ADT
干预措施: Apalutamide (Drug)
apalutamide combined with 89Sr and ADT
Experimental
Neoadjuvant therapy with apalutamide in combination with 89Sr and ADT
干预措施: 89Sr (Drug)
apalutamide combined with 89Sr and ADT
Experimental
Neoadjuvant therapy with apalutamide in combination with 89Sr and ADT
干预措施: Luteinizing Hormone-Releasing Hormone Analog (Drug)
结局指标
主要结局
PFS
时间窗: Up to 2 years after radical prostatectomy
progression-free survival
次要结局
- PSA response rate(Up to 3 years)
- rPFS(Up to 3 years)
- pCR(Up to 1 year)
- pain score(Measured at baseline and follow up visits throughout the study, an average of 3 years)
- number and extent of bone metastases(Up to 3 years)
研究者
Binshen Chen
associate chief physician
Zhujiang Hospital
研究点 (1)
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