NCT02669147已完成不适用
A Study to Determine Enzalutamide Long-term Safety and Efficacy After Anti-androgen Therapy for CRPC
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan0 个研究点目标入组 160 人开始时间: 2016年1月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This is a prospective observational study to evaluate effectiveness and safety of Enzalutamide for Castration Resistant Prostate Cancer (CRPC) patients who decided to administer Enzalutamide after anti-androgen therapy.
CRPC Patients who are observed PSA or disease progression after anti-androgen therapy and decided to administrate Enzalutamide will dose the Enzalutamide 160 mg orally once daily and observed the practical treatment. Total research term is for 4 years, consists of 2-year case registration terms and 2-year observational terms.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically or cytologically confirmed prostate cancer.
- •Patients who are receiving or received continuous androgen deprivation therapy using both gonadotropin-releasing hormone (GnRH) agonist and antagonist (medical castration), or both testicles removal by surgery (surgical castration).
- •Castration resistant prostate cancer (CRPC) patients who are observed disease progression after castration treatment and implied the treatment resistant.
- •CRPC patients who conducted anti-androgen alternating therapy as shown below 1) and are observed one or more of disease progression shown as below 2) during or after the therapy and decided to administer enzalutamide.
- •Note 1) anti-androgen alternating therapy is defined as the therapy of flutamide administration after bicalutamide.
- •Note 2) Disease progression criteria during or after anti-androgen alternating therapy
- •① PSA progression during or after anti-androgen alternating therapy: PSA increased more than 25% compare to the lowest test results after initial dose of anti-androgen alternating therapy (flutamide) and the increasing is more than 2ng/ml.
- •②Confirmed disease progression of soft tissue lesion defined as RECIST v1.
- •③Confirmed disease progression of bone lesion defined as 2 or more of new appearance of bone lesion on bone scintigraphy.
- •Patients with the Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Patients who have signed written informed consent to participate in this study
排除标准
- •Patients who is administering or have administration history of enzalutamide, abiraterone, docetaxel or cabazitaxel
- •Patients with history of seizure or predisposing disease of seizure
- •Patients with severe liver dysfunction
- •Patients with a previous history of hypersensitivity to any component of drugs which will be administered in this study
- •Patients who considered to be inappropriate for the study participation by the investigator
结局指标
主要结局
Overall survival (OS)
时间窗: 50 months
OS is defined as time from date of initial dose until date of death from any cause. In the case of any new chemotherapy added or changed to another treatment to prostate cancer, the conducted date will be applied. When patient is no longer traceable, the final confirmed date as alive will be applied to OS.
次要结局
- Prostate Specific Antigen-progression-free survival (PSA-PFS)(50 months)
- PSA response rate(50 months)
- The state of administration(2 years)
- Safety assessment(50 months)
- Time to Treatment Failure (TTTF)(50 months)
- Time-to-PSA-progression (TTPP)(50 months)
- Time to First Symptomatic Skeletal Events (TTFS)(50 months)
- Progression-free survival (PFS)(50 months)
研究者
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