A Randomized, Controlled, Double-blind, Single Center，Clinical Trial to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy（ADT）for High Risk Prostate Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response Rate
研究概览
简要总结
This trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Proxalutamide combined with androgen deprivation therapy（ADT）for High risk prostate cancer ，This trial is A randomized, controlled, double-blind, single center.Treatment cycle is 6 months,
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
- Single (Participant)
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
- •Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study
- •Patients must be ≥ 18，male
- •Histopathological by Prostate biopsy confirmed prostatic cancer（No Neuroendocrine prostate cancer or small cell carcinoma）
- •High-risk prostate cancer (T2c≤ clinical stage ≤T4 or Gleason score ≥8 or PSA≥20ng/ml)
- •Patients willing to undergo laparoscopic radical resection of prostate cancer and extensive lymph node dissection
- •ECOG PS：0-1
排除标准
- •Imaging or biopsy confirmed distant Metastatic lesion
- •The number of regional lymph nodes metastasis >3
- •Patients had undergone The treatment of Systemic chemotherapy and endocrine therapy for prostate cancer
- •Patients had undergone prostate surgery、radical radiotherapy or Bilateral orchidectomy
研究组 & 干预措施
placebo group
placebo+ADT
干预措施: placebo (Other)
Proxalutamide
Proxalutamide +ADT
干预措施: Proxalutamide (Drug)
结局指标
主要结局
Pathologic Complete Response Rate
时间窗: up to 6months
The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy
Proportion of Subjects With Minimal Residual Disease
时间窗: up to 6months
The proportion of subjects that have residual tumors with maximum diameter of 3 mm or less after radical prostatectomy
次要结局
未报告次要终点
研究者
Hongqian Guo
chief physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School