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 sites103 target enrollmentJanuary 23, 2015

ConditionsCastration-resistant prostate cancer

Overview

Phase: 未知
Intervention: Not specified
Conditions: Castration-resistant prostate cancer
Sponsor: Department of Urology, Osaka City University
Enrollment: 103
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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).

Registry

who.int

Start Date

January 23, 2015

End Date

September 30, 2018

Last Updated

2 years ago

Study Type

Interventional

Sex

Male

Investigators

Sponsor

Department of Urology, Osaka City University

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•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