Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
HanAll BioPharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01511874
First received: January 13, 2012
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Drug: ELIGARD 22.5mg
Phase 4

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

Resource links provided by NLM:


Further study details as provided by HanAll BioPharma Co., Ltd.:

Primary Outcome Measures:
  • Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dl at 4 weeks after injection of ELIGARD 22.5mg [ Time Frame: 4weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dL until 24weeks [ Time Frame: 24weeks ] [ Designated as safety issue: No ]
  • Ratio of subjects whose blood testosterone concentration exceed 50ng/dL until 24weeks [ Time Frame: 24weeks ] [ Designated as safety issue: No ]
  • Change in self assessment scale grade [ Time Frame: 0,4, 8, 12, 24 weeks ] [ Designated as safety issue: No ]
  • Ratio of subjects whose blood testosterone concentration is below 20ng/dL at 4weeks and 24weeks [ Time Frame: 4, 24 weeks ] [ Designated as safety issue: No ]
  • Change in ECOG performance status [ Time Frame: 0,4,8,12, 24weeks ] [ Designated as safety issue: No ]
  • Change in blood prostate-specific antigen [ Time Frame: 0,4,8,12,24 weeks ] [ Designated as safety issue: No ]
  • Change in QoL_EPIC grade [ Time Frame: 0,12, 24weeks ] [ Designated as safety issue: No ]
  • Change in penile length [ Time Frame: screening, 12, 24weeks ] [ Designated as safety issue: No ]
  • Change in testicular volume [ Time Frame: screening, 12, 24weeks ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: ELIGARD

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511874

Locations
Korea, Republic of
Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
HanAll BioPharma Co., Ltd.
Investigators
Principal Investigator: Byung Ha Chung, Medicine Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital
  More Information

No publications provided

Responsible Party: HanAll BioPharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01511874     History of Changes
Other Study ID Numbers: fr-HE530-01
Study First Received: January 13, 2012
Last Updated: March 4, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by HanAll BioPharma Co., Ltd.:
ELIGARD
Prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 14, 2014