Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer
Non-comparative, Opened Multicenter Study to Assess the Efficacy and Safety of ELIGARD 22.5mg in the Treatment of Subjects With Prostate Cancer
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 prostate-cancer
Started Jan 2011
Typical duration for phase_4 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 13, 2012
CompletedFirst Posted
Study publicly available on registry
January 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedSeptember 23, 2015
September 1, 2015
2.3 years
January 13, 2012
September 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dl at 4 weeks after injection of ELIGARD 22.5mg
4weeks
Secondary Outcomes (9)
Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dL until 24weeks
24weeks
Ratio of subjects whose blood testosterone concentration exceed 50ng/dL until 24weeks
24weeks
Change in self assessment scale grade
0,4, 8, 12, 24 weeks
Ratio of subjects whose blood testosterone concentration is below 20ng/dL at 4weeks and 24weeks
4, 24 weeks
Change in ECOG performance status
0,4,8,12, 24weeks
- +4 more secondary outcomes
Study Arms (1)
ELIGRAD 22.5mg
EXPERIMENTALa subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks
Interventions
a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Byung Ha Chung, Medicine
Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2012
First Posted
January 19, 2012
Study Start
January 1, 2011
Primary Completion
May 1, 2013
Study Completion
December 1, 2013
Last Updated
September 23, 2015
Record last verified: 2015-09