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.

Not Applicable

• Conditions: Castration-resistant prostate cancer

• Registration Number: JPRN-UMIN000016301
• Lead Sponsor: Department of Urology, Osaka City University

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).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-23
• Study Completion: 2018-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 103

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients whose prostate specific antigen (PSA) decreased 50 % or more 3 month after initiation

Secondary Outcome Measures

Name	Time	Method
1) Percentage of patients whose PSA decreased 50 % or more 6 month after initiation 2) Percentage of patients who showed disease progression 3 months after initiation 3) Percentage of patients who showed disease progression 6 months after initiation 4) PSA progression-free survival (PFS) 5) QOL measured by functional assessment of cancer therapy-prostate (FACT-P)