Long-Term Specified Drug Use-Results Survey for Xtandi Capsule

Completed

• Conditions: Castration-resistant Prostate Cancer
• Interventions: Drug: enzalutamide

• Registration Number: NCT02669771
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

The purpose of this study is to confirm the long term safety and efficacy of enzalutamide in patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-30
• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-02-01
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1018

Inclusion Criteria

• no history of treatment with enzalutamide

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Enzalutamide group	enzalutamide	oral

Primary Outcome Measures

Name	Time	Method
Incidences of Adverse Events	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Change from baseline in PSA value	Up to 2 years	PSA: prostate-specific antigen
Overall Survival	Up to 2 years