Status:
COMPLETED
Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer
Lead Sponsor:
HanAll BioPharma Co., Ltd.
Conditions:
Prostate Cancer
Eligibility:
MALE
20+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate efficacy and safety of ELIGARD 22.5mg in the treatment of subjects with prostate cancer.
Eligibility Criteria
Inclusion
- Male of 20 years or above
- Subject with prostate cancer with TNM stage T2\~4NxMx
- Blood testosterone concentration ≥ 100ng/dl
- Bilirubin ≤ 1.5xULN, transaminase ≤ 2.5xULN
- WHO ECOG performance status ≤ 2
- Signed written informed consent
Exclusion
- Hormone-Refractory Prostate cancer
- Brain metastasis
- Another primary malignant tumor except for prostate cancer
- Other conditions which in the opinion of the investigator preclude enrollment into the study
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01511874
Start Date
January 1 2011
End Date
December 1 2013
Last Update
September 23 2015
Active Locations (1)
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1
Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital
Seoul, South Korea