Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer

HanAll Biopharma

Status and phase: Completed; Phase 4

Conditions: Prostate Cancer

Treatments: Drug: ELIGARD 22.5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01511874

fr-HE530-01

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: Male

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

ELIGRAD 22.5mg

Experimental group

Description:

a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks

Treatment:

Drug: ELIGARD 22.5mg