Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
Prostate cancer is the 2nd most common cancer in men worldwide. Based on the results of several recent clinical trials, systemic treatments including hormone inhibitors, docetaxel, cabazitaxel, and PARP inhibitors are being used as standard treatment for patients with metastatic castration-resistant prostate cancer. However, there is insufficient research on salvage therapy for patients with metastatic castration-resistant prostate cancer who have failed standard treatment. In this study, the investigators will evaluate the effectiveness and safety of ifosfamide in castration-resistant prostate cancer by analyzing the treatment outcomes of patients who received ifosfamide/mesna treatment as salvage therapy.
详细描述
- Retrospective analysis of the treatment outcomes of patients with metastatic castration-resistant prostate cancer who who received ifosfamide/mesna will be conducted.
- Information regarding demographics (age, gender, and etc.), disease status (stage, metastatic lesion, and etc.), treatment details (administered anticancer drugs, treatment response to drug, and disease progression with progression date), and survival (death with date of death) will be recorded.
- Statistical method was applied to analyze the correlation between clinical indicators and survival rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •19 years and older adult male
- •Patients with histologically confirmed prostate cancer
- •Castration-resistant prostate cancer
- •ECOG 2 or less
- •Patients with previous docetaxel exposure
- •Patients with available PSA level
- •Patients with evaluable disease based on RECIST 1.1
排除标准
- •Patients with other primary cancers diagnosed within 3 years other than prostate cancer
- •Patients with a history of organ transplantation
- •Hormone sensitive prostate cancer
- •ECOG 3 or higher
- •Patients without previous docetaxel exposure
- •Patients previously exposed to ifosfamide
- •Patients without available PSA level
- •Patients without evaluable disease based on RECIST 1.1
研究组 & 干预措施
Castration-resistant prostate cancer patients treated with ifosfamide/mesna
干预措施: Ifosfamide/mesna (Drug)
结局指标
主要结局
Objective response rate
时间窗: Up to 2 years
Summation of complete response partial response based on RECIST version 1.1
次要结局
- Overall survival(Up to 2 years)
- Number of patients with Adverse events based on CTCAE(Up to 2 years)