A Non-interventional Study of Immediate Postoperative Adjuvant Hormonal Treatment in High Risk Localised or Locally Advanced Chinese Prostate Cancer Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To assess the efficacy of immediate postoperative adjuvant hormonal treatment according to 2 year PSA recurrence rate in high risk localised or locally advanced Chinese prostate cancer patients.
研究概览
简要总结
The primary objective is to assess the efficacy of immediate postoperative adjuvant hormonal treatment according to 2 year PSA recurrence rate in high risk localised or locally advanced Chinese prostate cancer patients.The secondary objective is to assess the quality of life（QoL）of the high risk localised or locally advanced Chinese prostate cancer patients with immediate postoperative adjuvant hormonal treatment and get the information of immediate postoperative adjuvant hormonal treatment (including the regimen, dosage and duration).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Localised with one of any high recurrence risk factors(Gleason score≥8 or preoperative serum PSA≥20ng/ml), or locally advanced(T≥pT3、N0M0 and any T、N（+）M0 ) Chinese prostate cancer patients confirmed histologically through radical prostatectomy either with laparoscopy or laparotomy within 1 month after surgery. Before the patient recruitment, the investigator has decided to prescribe immediate postoperative adjuvant hormonal treatment to the patient according to the Chinese routine practice.
- •Provision of written informed consent prior to any study specific procedures.
排除标准
- •Patients must not enter the study if any of the following exclusion criteria are fulfilled
- •Have used neoadjuvant hormonal treatment prior to the surgery.
结局指标
主要结局
To assess the efficacy of immediate postoperative adjuvant hormonal treatment according to 2 year PSA recurrence rate in high risk localised or locally advanced Chinese prostate cancer patients.
时间窗: Up to 2 years
次要结局
- Get the information of immediate postoperative adjuvant hormonal treatment (including the regimen, dosage and duration).(Up to 2 years)
- To assess the quality of life（QoL）of the high risk localised or locally advanced Chinese prostate cancer patients with immediate postoperative adjuvant hormonal treatment.(Up to 2 years)