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


Phase 4
20 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

4weeks

Safety Issue:

No

Principal Investigator

Byung Ha Chung, Medicine

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Korea: Food and Drug Administration

Study ID:

fr-HE530-01

NCT ID:

NCT01511874

Start Date:

January 2011

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • ELIGARD
  • Prostate cancer
  • Prostatic Neoplasms

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