Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
1454 participants
OBSERVATIONAL
2019-08-20
2022-12-31
Brief Summary
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Study Design
This study is a multi-center, single-arm, non-interventional, prospective study among Chinese participants with prostate cancer in need of ADT, receiving treatment with FIRMAGON®. This program provided the minimum 6 doses and maximum 12 doses of FIRMAGON® to enrolled participants during one-year follow-up. Participants who met the inclusion criteria would or were accepting at least 6 self-financed doses of treatment in a hospital. Participants should return to the hospital for medical assessment every three months. The prescription of 6 (3 doses × 2 times) self-financed doses will be given by doctors after assessment, and the direct-to-participant pharmacy will distribute FIRMAGON® to eligible participants (participants should bring the prescriptions and the last FIRMAGON® boxes to get other doses). All enrolled participants were followed up to collect safety information for one year from the 1st dose unless withdrawal of Informed Consent Form, discontinuation for 2 months, lost to follow-up, death, or termination due to other reasons, whichever came first.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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FIRMAGON® Cohort
Degarelix Cohort
Non-interventional
Interventions
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Degarelix Cohort
Non-interventional
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Decision made to prescribe FIRMAGON® prior to enrollment
* Willingness and ability to provide written informed consent
* The participants are taking the marketed drug FIRMAGON®
Exclusion Criteria
* Any participants who are unsuitable to participate in this study because of any other reasons will not be qualified to participate in this study.
18 Years
MALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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China Primary Healthcare Foundation
Beijing, , China
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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000351
Identifier Type: -
Identifier Source: org_study_id
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