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Completed

NCT Number: NCT01511874

Efficacy and Safety Study of ELIGARD 22.5mg 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

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

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ELIGARD 22.5mg

Drug

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

Other names: ELIGARD

Primary outcomes

  1. 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

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

    Time frame: 24weeks

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

    Time frame: 24weeks

  3. Change in self assessment scale grade

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

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

    Time frame: 4, 24 weeks

  5. Change in ECOG performance status

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

  6. Change in blood prostate-specific antigen

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

  7. Change in QoL_EPIC grade

    Time frame: 0,12, 24weeks

  8. Change in penile length

    Time frame: screening, 12, 24weeks

  9. Change in testicular volume

    Time frame: screening, 12, 24weeks

Sponsors and collaborators

Lead sponsor

HanAll BioPharma Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 19, 2012
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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