Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer

Phase 4

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: ELIGARD 22.5mg

• Registration Number: NCT01511874
• Lead Sponsor: HanAll BioPharma Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-01-13
• Study First Submitted QC: 2012-01-18
• Study First Posted: 2012-01-19
• Primary Completion: 2013-05
• Study Completion: 2013-12
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ELIGRAD 22.5mg	ELIGARD 22.5mg	a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks

Primary Outcome Measures

Name	Time	Method
Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dl at 4 weeks after injection of ELIGARD 22.5mg	4weeks

Secondary Outcome Measures

Name	Time	Method
Change in QoL_EPIC grade	0,12, 24weeks
Change in penile length	screening, 12, 24weeks
Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dL until 24weeks	24weeks
Change in ECOG performance status	0,4,8,12, 24weeks
Change in blood prostate-specific antigen	0,4,8,12,24 weeks
Change in self assessment scale grade	0,4, 8, 12, 24 weeks
Change in testicular volume	screening, 12, 24weeks
Ratio of subjects whose blood testosterone concentration exceed 50ng/dL until 24weeks	24weeks
Ratio of subjects whose blood testosterone concentration is below 20ng/dL at 4weeks and 24weeks	4, 24 weeks

Trial Locations

Locations (1)

Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of