Long-Term Specified Drug Use-Results Survey for Xtandi Capsule
Xtandi® Capsules 40 mg Protocol for Long-Term Specified Drug Use-Results Survey
1 other identifier
observational
1,018
1 country
47
Brief Summary
The purpose of this study is to confirm the long term safety and efficacy of enzalutamide in patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2014
Longer than P75 for all trials
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 30, 2014
CompletedFirst Submitted
Initial submission to the registry
January 28, 2016
CompletedFirst Posted
Study publicly available on registry
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2018
CompletedNovember 21, 2024
November 1, 2024
4 years
January 28, 2016
November 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidences of Adverse Events
Up to 2 years
Secondary Outcomes (2)
Overall Survival
Up to 2 years
Change from baseline in PSA value
Up to 2 years
Study Arms (1)
Enzalutamide group
oral
Interventions
Eligibility Criteria
Patients with castration-resistant prostate cancer
You may qualify if:
- no history of treatment with enzalutamide
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Pfizercollaborator
Study Sites (47)
Unknown Facility
Numakunai, Iwate, Japan
Unknown Facility
Aichi, Japan
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Akita, Japan
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Aomori, Japan
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Chiba, Japan
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Ehime, Japan
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Fukui, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Gifu, Japan
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Gunma, Japan
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Hiroshima, Japan
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Hokkaido, Japan
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Hyōgo, Japan
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Ibaraki, Japan
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Ishikawa, Japan
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Kagawa, Japan
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Kagoshima, Japan
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Kanagawa, Japan
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Kochi, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Mie, Japan
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Miyagi, Japan
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Miyazaki, Japan
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Nagano, Japan
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Nagasaki, Japan
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Nara, Japan
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Niigata, Japan
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Okayama, Japan
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Okinawa, Japan
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Osaka, Japan
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Ōita, Japan
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Saga, Japan
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Saitama, Japan
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Shiga, Japan
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Shimane, Japan
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Shizuoka, Japan
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Tochigi, Japan
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Tokushima, Japan
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Tokyo, Japan
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Tottori, Japan
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Toyama, Japan
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Wakayama, Japan
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Yamagata, Japan
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Yamaguchi, Japan
Unknown Facility
Yamanashi, Japan
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2016
First Posted
February 1, 2016
Study Start
November 30, 2014
Primary Completion
November 30, 2018
Study Completion
November 30, 2018
Last Updated
November 21, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.