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

Xtandi® Capsules 40 mg Protocol for Long-Term Specified Drug Use-Results Survey

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02669771

Enrollment

1018

Registered

2016-02-01

Start date

2014-11-30

Completion date

2018-11-30

Last updated

2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Castration-resistant Prostate Cancer

Keywords

Xtandi, MDV3100, long term use, enzalutamide

Brief summary

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

Interventions

DRUGenzalutamide

oral

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Healthy volunteers

Inclusion criteria

* no history of treatment with enzalutamide

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
Incidences of Adverse Events	Up to 2 years

Secondary

Measure	Time frame	Description
Overall Survival	Up to 2 years	—
Change from baseline in PSA value	Up to 2 years	PSA: prostate-specific antigen

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026