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Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

ELIGARD 22.5mg

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring ELIGARD, Prostate cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ELIGRAD 22.5mg

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Change in self assessment scale grade

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

Change in ECOG performance status

Change in blood prostate-specific antigen

Change in QoL_EPIC grade

Change in penile length

Change in testicular volume

Full Information

NCT ID

NCT01511874

First Posted

January 13, 2012

Last Updated

September 21, 2015

Sponsor

HanAll BioPharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01511874

Brief Title

Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HanAll BioPharma Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

ELIGARD, Prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ELIGRAD 22.5mg

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ELIGARD 22.5mg

Other Intervention Name(s)

ELIGARD

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Time Frame

24weeks

Title

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

Time Frame

24weeks

Title

Change in self assessment scale grade

Time Frame

0,4, 8, 12, 24 weeks

Title

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

Time Frame

4, 24 weeks

Title

Change in ECOG performance status

Time Frame

0,4,8,12, 24weeks

Title

Change in blood prostate-specific antigen

Time Frame

0,4,8,12,24 weeks

Title

Change in QoL_EPIC grade

Time Frame

0,12, 24weeks

Title

Change in penile length

Time Frame

screening, 12, 24weeks

Title

Change in testicular volume

Time Frame

screening, 12, 24weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Byung Ha Chung, Medicine

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer

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