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

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

Completed

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Key information

Conditions

Castration-resistant Prostate Cancer

Sex eligibility

Male

Study type

Observational

Primary location

Numakunai, Iwate, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

no history of treatment with enzalutamide

Exclusion criteria

Treatment and study plan

Enzalutamide

Drug

oral

Other names: Xtandi, MDV3100

Primary outcomes

Incidences of Adverse Events

Time frame: Up to 2 years

Secondary outcomes

Overall Survival

Time frame: Up to 2 years
Change from baseline in PSA value

Time frame: Up to 2 years

PSA: prostate-specific antigen

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

Pfizer

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Feb 1, 2016
Registry last updated: Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed