Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer

September 21, 2015 updated by: HanAll BioPharma Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ELIGRAD 22.5mg
a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks
Drug: ELIGARD 22.5mg
a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks
Other Names:
  • ELIGARD

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HanAll BioPharma Co., Ltd.

Investigators

  • Principal Investigator: Byung Ha Chung, Medicine, Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 13, 2012

First Submitted That Met QC Criteria

January 18, 2012

First Posted (Estimate)

January 19, 2012

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fr-HE530-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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