Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma in Argentina
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) failure rate (with failure defined as either prostate-specific antigen (PSA) failure, introduction of additional therapy related to prostate cancer, or death)
研究概览
简要总结
Prospective, observational study to collect and analyze data on patients with advanced hormone dependent prostate cancer treated with Firmagon® according to routine medical practice in Argentina
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Advanced Prostate Cancer patients to be treated with Firmagon in the context of usual clinical practice
- •Written informed consent
排除标准
- •Contraindications to Firmagon
- •Patients already on Firmagon therapy
研究组 & 干预措施
Advanced Prostate Cancer
Advanced Prostate Cancer that receive Firmagon therapy in the context of usual clinical practice
干预措施: Firmagon® (degarelix) (Drug)
结局指标
主要结局
Progression-free survival (PFS) failure rate (with failure defined as either prostate-specific antigen (PSA) failure, introduction of additional therapy related to prostate cancer, or death)
时间窗: During 3 years treatment
The PFS failure rate will be estimated with time to PFS failure as dependent and adjusting for disease stage at baseline, baseline PSA, baseline testosterone (if available) and baseline serum Alkaline Phosphatase (s-ALP, if available)
次要结局
未报告次要终点