Trial Information
Non-comparative, Opened Multicenter Study to Assess the Efficacy and Safety of ELIGARD 22.5mg in the Treatment of Subjects With Prostate Cancer
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dl at 4 weeks after injection of ELIGARD 22.5mg
Outcome Time Frame:
4weeks
Safety Issue:
No
Principal Investigator
Byung Ha Chung, Medicine
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital
Authority:
Korea: Food and Drug Administration
Study ID:
fr-HE530-01
NCT ID:
NCT01511874
Start Date:
January 2011
Completion Date:
December 2013
Related Keywords:
- Prostate Cancer
- ELIGARD
- Prostate cancer
- Prostatic Neoplasms