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A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period.
Subjects must continue on the treatment regimen that the subject was receiving in the prior study. Dose changes of any of the prior therapies subjects were receiving on the previous protocol are allowed after medical monitor approval. The day 1 visit for this study should coincide with the last treatment visit for the study the subject will be enrolling from (≤ 7 days post last visit of parent study). The subjects will be followed according to the local institution's standard of care and will be required to return to the institution every 24 weeks (± 7 days) to review adverse events (AEs), collect concomitant medications and confirm that no discontinuation criteria are met. At each visit and at every 12 weeks (IP only visit) subjects are to return all dispensed study drug and to receive more study drug if applicable. All AEs (new and ongoing from the study the subject is enrolling from) and Serious Adverse Events (SAEs) (including death), will be collected from the time the subject signs the consent form until the end of study visit. After the marketing approval in South Korea, this study continued as "post marketing clinical study" in South Korea. In the rest of the countries which participated in this study, this study continued as clinical study.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Site US10052
Anchorage, Alaska, United States
Site US10011
Tucson, Arizona, United States
Site US10040
Los Angeles, California, United States
Site US10009
Los Angeles, California, United States
Site US10067
Orange, California, United States
Site US10008
San Bernardino, California, United States
Site US10042
San Diego, California, United States
Site US10028
Stanford, California, United States
Site US10001
Aurora, Colorado, United States
Site US10017
Denver, Colorado, United States
Start Date
December 22, 2016
Primary Completion Date
July 31, 2029
Completion Date
July 31, 2029
Last Updated
December 17, 2025
900
ESTIMATED participants
enzalutamide
DRUG
abiraterone acetate
DRUG
prednisone
DRUG
Leuprolide acetate
DRUG
Lead Sponsor
Astellas Pharma Global Development, Inc.
Collaborators
NCT05691465
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
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