A study to Determine Enzalutamide Long-term safety and efficacy after anti-androgen therapy for CRPC.

Not Applicable

Recruiting

• Conditions: Castration resistant prostate cancer (CRPC)

• Registration Number: JPRN-UMIN000019855
• Lead Sponsor: Osaka University Graduate School Of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patients who is administering or have administration history of enzalutamide, abiraterone, docetaxel or cabazitaxel 2)Patients with history of seizure or predisposing disease of seizure 3)Patients with severe liver dysfunction 4)Patients with a previous history of hypersensitivity to any component of drugs which will be administered in this study 5)Patients who considered to be inappropriate for the study participation by the investigator

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)

Secondary Outcome Measures

Name	Time	Method
1)PSA-PFS (prostate specific antigen)-(progression-free survival) 2) Progression-free survival (PFS) 3) Time to treatment failure (TTTF) 4) Time-to-PSA-progression (TTPP) 5) PSA response rate 6)Time to first symptomatic skeletal event (TTFS) (or Time to First SSE) 7) medication adherence 8) Safety assessment by the incidence and severity of adverse events as assessed by Japanese version of CTCAE v4.00)