Multicenter, Prospective, Randomised and Comparative Study of AA Therapy and Early Administrating Enzalutamide in Participants With CRPC Previously Treated With CAB Therapy Using Bicalutamide.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Percentage of participants whose prostate specific antigen (PSA) decreased 50 percent or more at month 3
研究概览
简要总结
The objective of this study is to compare the efficacy and safety of enzalutamide or alternative AA therapy in CRPC participants who were previously treated with a combined androgen blockade therapy which included bicalutamide (Bic-CAB). Efficacy and safety of enzalutamide and alternative AA therapy will be evaluated, and effective therapy against CRPC after treatment with Bic-CAB will be investigated.
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
- None
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
- •Testosterone of less than 50 ng/dL
- •Participants who was detected of disease progression on image or relapse of PSA (All PSA values measured 3 time at least one week interval are consecutively increased and final value is 2 ng/mL or more. If third value is not higher than second one, fourth measurement will be undertaken and its value must be higher than second one.)
- •Participants who relapsed after CAB with bicalutamide
- •Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1
- •Aged 20 years or older
- •Participants who provided written informed consent
排除标准
- •Any prior treatment with enzalutamide, flutamide, abiraterone or chemotherapy, except for neoadjuvant therapy
- •With active double cancer
- •Any prior treatment with bicalutamide within 6 weeks
- •Participants who received systemic biological therapy (except for existing approved drug for bone or treatment with luteinizing hormone-releasing hormone (LHRH) analogue) or received treatment with other antitumor agent for prostate cancer
- •With serious complication
- •History of hypersensitivity to enzalutamide or any other excipient of enzalutamide
- •History of hypersensitivity to flutamide-containing agent
- •With liver dysfunction
- •Participants who are considered as inadequate by the investigator
研究组 & 干预措施
Enzalutamide
Enzalutamide 160 mg administered orally once a day as four 40-mg soft capsules
干预措施: Enzalutamide (Drug)
Flutamide
Flutamide 125 mg administered orally three times a day as one tablet after meal
干预措施: Flutamide (Drug)
结局指标
主要结局
Percentage of participants whose prostate specific antigen (PSA) decreased 50 percent or more at month 3
时间窗: Month 3
次要结局
- Percentage of participants who showed disease progression at month 6(Month 6)
- PSA progression-free survival (PFS)(Up to 39 months)
- QOL measured by functional assessment of cancer therapy-prostate (FACT-P)(Up to 39 months)
- Percentage of participants whose PSA decreased 50 percent or more at month 6(Month 6)
- Percentage of participants who showed disease progression at month 3(Month 3)
研究者
Taro Iguchi, MD, PHD
Osaka City University Graduate School of Medicine
Osaka City University