Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate efficacy and safety of ELIGARD 22.5mg in the treatment of subjects with prostate cancer.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HanAll BioPharma Co., Ltd.
• Treatments: Leuprolide

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