NCT00127088暂停2 期
A Prospective Phase II of Peri-Operative Docetaxel + Laparoscopic Radical Prostatectomy in Patients With Localized Gleason 7 pT2a-pT2b Adenocarcinoma and a Risk of Relapse After Radical Prostatectomy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Complete prostate specific antigen (PSA) response rate
研究概览
简要总结
This is a prospective phase II study of peri-operative docetaxel plus laparoscopic radical prostatectomy in patients with localized Gleason 7 pT2a-pT2b adenocarcinoma of the prostate and a risk of relapse after radical prostatectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years and less than 70 years
- •Histologically-proven Gleason 7 adenocarcinoma of the prostate
- •pT2a or pT2b disease based on biopsies of the prostate
- •More than 2/3 of positive biopsies or 15 ≤ serum PSA <20
- •No previous carcinoma, except basal-cell carcinoma of the skin
- •Adequate renal function: measured or calculated creatinine clearance> 60 ml/min
- •Absolute granulocyte count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5 fold the upper normal value
- •Signed informed consent.
排除标准
- •Patients infected by the Human Immunodeficiency Virus (HIV)
- •Contra-indication to general anesthesia or surgery
- •Patients who do not fit inclusion criteria
结局指标
主要结局
Complete prostate specific antigen (PSA) response rate
次要结局
- Toxicity
- Pathological response rate
- Progression free survival
- Overall survival
研究者
研究点 (2)
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