Clinical trial · Interventional
Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer
Non-comparative, Opened Multicenter Study to Assess the Efficacy and Safety of ELIGARD 22.5mg in the Treatment of Subjects With Prostate Cancer
NCT01511874CI-TRIAL-00019191completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate efficacy and safety of ELIGARD 22.5mg in the treatment of subjects with prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ELIGARD 22.5mg | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ELIGRAD 22.5mg
- description
- a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks
- interventionNames
- Drug: ELIGARD 22.5mg
Primary outcomes (1)
- measure
- Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dl at 4 weeks after injection of ELIGARD 22.5mg
- timeFrame
- 4weeks
Secondary outcomes (9)
- measure
- Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dL until 24weeks
- timeFrame
- 24weeks
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.