Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer
Information source: HanAll BioPharma Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: ELIGARD 22.5mg (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: HanAll BioPharma Co., Ltd. Official(s) and/or principal investigator(s):
Byung Ha Chung, Medicine, Principal Investigator, Affiliation: Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital
Summary
The purpose of this study is to evaluate efficacy and safety of ELIGARD 22. 5mg in the
treatment of subjects with prostate cancer.
Clinical Details
Official title: Non-comparative, Opened Multicenter Study to Assess the Efficacy and Safety of ELIGARD 22.5mg in the Treatment of Subjects With Prostate Cancer
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dl at 4 weeks after injection of ELIGARD 22.5mg
Secondary outcome: Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dL until 24weeksRatio of subjects whose blood testosterone concentration exceed 50ng/dL until 24weeks Change in self assessment scale grade Ratio of subjects whose blood testosterone concentration is below 20ng/dL at 4weeks and 24weeks Change in ECOG performance status Change in blood prostate-specific antigen Change in QoL_EPIC grade Change in penile length Change in testicular volume
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital, Seoul, Korea, Republic of
Additional Information
Starting date: January 2011
Last updated: March 4, 2013
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