JPRN-UMIN000016301已完成未知
Multicenter, prospective, randomised and comparative study of alternative anti-androgen (AA) therapy and early initiating enzalutamide for castration-resistant prostate cancer (CRPC) after combined androgen blockade (CAB) therapy with bicalutamide. - Multicenter, prospective, randomised and comparative study of alternative anti-androgen (AA) therapy and early initiating enzalutamide for castration-resistant prostate cancer (CRPC) after combined androgen blockade (CAB) therapy with bicalutamide.
Department of Urology, Osaka City University0 个研究点目标入组 103 人开始时间: 2015年1月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 103
研究概览
简要总结
The 3- (80.8% vs. 35.3%; p <0.001) and 6-month (73.1% vs. 31.4%; p <0.001) prostate-specific antigen response rates were higher in the enzalutamide than in the flutamide group. The 3-month disease progression rates were 6.4% and 38.8% in the enzalutamide and flutamide groups, respectively [HR: 0.16; 95% CI: 0.05-0.47; p <0.001]; the 6-month rates were 11.4% and 51.1%, respectively (HR 0.22; 95% CI 0.09-0.50; p <0.001).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- Male
入选标准
- 未提供
排除标准
- •1) Any prior treatment with enzalutamide, flutamide, abiraterone or chemotherapy except for neoadjuvant therapy 2) With active double cancer 3) Any prior treatment with bicalutamide within 6 weeks 4) Patients who received systemic biological therapy for prostate cancer (except for existing approved drug for bone or treatment with LHRH analogue), or received treatment with other antitumor agent for prostate cancer 5) With serious complication 6) Has history of hypersensitivity to enzalutamide or any excipient of enzalutamide 7) Has history of hypersensitivity to flutamide-containing agent 8) With liver dysfunction 9) With considered as inadequate by the investigator
研究者
相似试验
已完成
4 期
A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC)Prostatic NeoplasmsNCT04108208Janssen Research & Development, LLC75
已完成
3 期
Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer PatientsProstate CancerNCT00884273Ferring Pharmaceuticals182
Unknown
3 期
Androgen Suppression Combined With Elective Nodal and Dose Escalated Radiation TherapyProstate CancerNCT00175396University of British Columbia400
Unknown
不适用
Study Comparing MRI/Ultrasound Fusion-guided Prostate Biopsy Versus Systematic Transrectal Ultrasound-guided BiopsyProstate CancerNCT02450266Heinrich-Heine University, Duesseldorf586
已完成
3 期
Study of Immunotherapy to Treat Advanced Prostate CancerProstate CancerNCT00861614Bristol-Myers Squibb988