Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Non-comparative, Opened Multicenter Study to Assess the Efficacy and Safety of ELIGARD 22.5mg in the Treatment of Subjects With Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511874
• Other study ID #: fr-HE530-01
• Status: Completed
• Phase: Phase 4
• First received: January 13, 2012
• Last updated: September 21, 2015
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: September 2015
• Source: HanAll BioPharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
HanAll BioPharma Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dl at 4 weeks after injection of ELIGARD 22.5mg		4weeks	No
Secondary	Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dL until 24weeks		24weeks	No
Secondary	Ratio of subjects whose blood testosterone concentration exceed 50ng/dL until 24weeks		24weeks	No
Secondary	Change in self assessment scale grade		0,4, 8, 12, 24 weeks	No
Secondary	Ratio of subjects whose blood testosterone concentration is below 20ng/dL at 4weeks and 24weeks		4, 24 weeks	No
Secondary	Change in ECOG performance status		0,4,8,12, 24weeks	No
Secondary	Change in blood prostate-specific antigen		0,4,8,12,24 weeks	No
Secondary	Change in QoL_EPIC grade		0,12, 24weeks	No
Secondary	Change in penile length		screening, 12, 24weeks	No
Secondary	Change in testicular volume		screening, 12, 24weeks	No