The Role of HER Receptor Family as Indicator of Prognosis and Drug Responsiveness in Locally Advanced Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- PSA recurrence rate stratified according to treatment modalities
研究概览
简要总结
As clinical primary endpoints we assessed whether existed differences in:
- PSA recurrence rate stratified according to treatment modalities
- EGFR and HER2/neu overexpression rate stratified according to treatment modalities
- PSA recurrence rate stratified according to EGFR and HER2/neu overexpression levels.
As secondary clinical endpoints we assessed whether existed differences in:
- prostate cancer-specific mortality according to treatment modalities
- prostate cancer-specific mortality stratified according to EGFR and HER2/neu overexpression levels.
For this purpose a post treatment PSA-doubling time of less than 3 months found following PSA recurrence was considered as a surrogate endpoint for prostate cancer-specific mortality Pre-clinical endpoints As pre-clinical endpoint we assessed whether exist differences in efficacy rate of Bicalutamide and Gefitinib treatment in primary tumor cultures stratified for high and low EGFR and HER2/Neu expression levels. The evaluation of efficacy rate of these treatments was documented by comparing the differences of drugs IC50 values among the groups stratified for EGFR and HER2/Neu levels.
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
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients were eligible if they had histologically confirmed adenocarcinoma of the prostate and the following high-risk features: (1) clinical stage T3a disease with (2) Gleason sum of 7 with a predominant component of 4 (i.e., Gleason 4 + 3 = 7) or (4) Gleason sum of 8, 9 or 10.
排除标准
- •Prior hormonal therapy,
- •Prior radiation,
- •Prior investigational agents,
- •Prior malignancy within the last five years or had any other serious medical or psychiatric condition or illness that would not permit the patient to be managed according to the protocol were excluded.
结局指标
主要结局
PSA recurrence rate stratified according to treatment modalities
EGFR and HER2/neu overexpression rate stratified according to treatment modalities
PSA recurrence rate stratified according to EGFR and HER2/neu overexpression levels.
次要结局
- Prostate cancer-specific mortality according to treatment modalities
- Prostate cancer-specific mortality stratified according to EGFR and HER2/neu overexpression levels.
- For this purpose a post treatment PSA-doubling time of less than 3 months found following PSA recurrence was considered as a surrogate endpoint for prostate cancer-specific mortality.