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

November 19, 2024 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1018

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan
      • Akita, Japan
      • Aomori, Japan
      • Chiba, Japan
      • Ehime, Japan
      • Fukui, Japan
      • Fukuoka, Japan
      • Fukushima, Japan
      • Gifu, Japan
      • Gunma, Japan
      • Hiroshima, Japan
      • Hokkaido, Japan
      • Hyogo, Japan
      • Ibaraki, Japan
      • Ishikawa, Japan
      • Iwate, Japan
      • Kagawa, Japan
      • Kagoshima, Japan
      • Kanagawa, Japan
      • Kochi, Japan
      • Kumamoto, Japan
      • Kyoto, Japan
      • Mie, Japan
      • Miyagi, Japan
      • Miyazaki, Japan
      • Nagano, Japan
      • Nagasaki, Japan
      • Nara, Japan
      • Niigata, Japan
      • Oita, Japan
      • Okayama, Japan
      • Okinawa, Japan
      • Osaka, Japan
      • Saga, Japan
      • Saitama, Japan
      • Shiga, Japan
      • Shimane, Japan
      • Shizuoka, Japan
      • Tochigi, Japan
      • Tokushima, Japan
      • Tokyo, Japan
      • Tottori, Japan
      • Toyama, Japan
      • Wakayama, Japan
      • Yamagata, Japan
      • Yamaguchi, Japan
      • Yamanashi, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with castration-resistant prostate cancer

Description

Inclusion Criteria:

  • no history of treatment with enzalutamide

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Enzalutamide group
oral
Drug: enzalutamide
oral
Other Names:
  • Xtandi
  • MDV3100

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidences of Adverse Events
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Pfizer

Investigators

  • Study Director: Medical Director, Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2014

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

January 28, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimated)

February 1, 2016

Study Record Updates

Last Update Posted (Actual)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9785-MA-1018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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