Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer

HanAll BioPharma Co., Ltd.42 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

ELIGARD 22.5mgDRUG

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

Eligibility

Sex: MALEMin age: 20 Years

Medical Language ↔ Plain English

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 (1)

Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: 4weeks

Secondary Outcomes

Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dL until 24weeks

Time frame: 24weeks

Ratio of subjects whose blood testosterone concentration exceed 50ng/dL until 24weeks

Time frame: 24weeks

Change in self assessment scale grade

Time frame: 0,4, 8, 12, 24 weeks

Ratio of subjects whose blood testosterone concentration is below 20ng/dL at 4weeks and 24weeks

Time frame: 4, 24 weeks

Change in ECOG performance status

Time frame: 0,4,8,12, 24weeks

Change in blood prostate-specific antigen

Time frame: 0,4,8,12,24 weeks

Change in QoL_EPIC grade

Time frame: 0,12, 24weeks

Change in penile length

Time frame: screening, 12, 24weeks

Change in testicular volume

Time frame: screening, 12, 24weeks

Data from ClinicalTrials.gov

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