{
  "FullStudy":{
    "Rank":218166,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01511874",
          "OrgStudyIdInfo":{
            "OrgStudyId":"fr-HE530-01"
          },
          "Organization":{
            "OrgFullName":"HanAll BioPharma Co., Ltd.",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer",
          "OfficialTitle":"Non-comparative, Opened Multicenter Study to Assess the Efficacy and Safety of ELIGARD 22.5mg in the Treatment of Subjects With Prostate Cancer"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"May 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 13, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 21, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 23, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"HanAll BioPharma Co., Ltd.",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to evaluate efficacy and safety of ELIGARD 22.5mg in the treatment of subjects with prostate cancer."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Prostate Cancer"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "ELIGARD",
              "Prostate cancer"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 4"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"42",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"ELIGRAD 22.5mg",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: ELIGARD 22.5mg"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"ELIGARD 22.5mg",
                "InterventionDescription":"a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "ELIGRAD 22.5mg"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "ELIGARD"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dl at 4 weeks after injection of ELIGARD 22.5mg",
                "PrimaryOutcomeTimeFrame":"4weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dL until 24weeks",
                "SecondaryOutcomeTimeFrame":"24weeks"
              },{
                "SecondaryOutcomeMeasure":"Ratio of subjects whose blood testosterone concentration exceed 50ng/dL until 24weeks",
                "SecondaryOutcomeTimeFrame":"24weeks"
              },{
                "SecondaryOutcomeMeasure":"Change in self assessment scale grade",
                "SecondaryOutcomeTimeFrame":"0,4, 8, 12, 24 weeks"
              },{
                "SecondaryOutcomeMeasure":"Ratio of subjects whose blood testosterone concentration is below 20ng/dL at 4weeks and 24weeks",
                "SecondaryOutcomeTimeFrame":"4, 24 weeks"
              },{
                "SecondaryOutcomeMeasure":"Change in ECOG performance status",
                "SecondaryOutcomeTimeFrame":"0,4,8,12, 24weeks"
              },{
                "SecondaryOutcomeMeasure":"Change in blood prostate-specific antigen",
                "SecondaryOutcomeTimeFrame":"0,4,8,12,24 weeks"
              },{
                "SecondaryOutcomeMeasure":"Change in QoL_EPIC grade",
                "SecondaryOutcomeTimeFrame":"0,12, 24weeks"
              },{
                "SecondaryOutcomeMeasure":"Change in penile length",
                "SecondaryOutcomeTimeFrame":"screening, 12, 24weeks"
              },{
                "SecondaryOutcomeMeasure":"Change in testicular volume",
                "SecondaryOutcomeTimeFrame":"screening, 12, 24weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nMale of 20 years or above\nSubject with prostate cancer with TNM stage T2~4NxMx\nBlood testosterone concentration ≥ 100ng/dl\nBilirubin ≤ 1.5xULN, transaminase ≤ 2.5xULN\nWHO ECOG performance status ≤ 2\nSigned written informed consent\n\nExclusion Criteria:\n\nHormone-Refractory Prostate cancer\nBrain metastasis\nAnother primary malignant tumor except for prostate cancer\nOther conditions which in the opinion of the investigator preclude enrollment into the study",
          "HealthyVolunteers":"No",
          "Gender":"Male",
          "MinimumAge":"20 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Byung Ha Chung, Medicine",
                "OverallOfficialAffiliation":"Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital",
                "LocationCity":"Seoul",
                "LocationCountry":"Korea, Republic of"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000016729",
                "InterventionMeshTerm":"Leuprolide"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000005300",
                "InterventionAncestorTerm":"Fertility Agents, Female"
              },{
                "InterventionAncestorId":"D000005299",
                "InterventionAncestorTerm":"Fertility Agents"
              },{
                "InterventionAncestorId":"D000012102",
                "InterventionAncestorTerm":"Reproductive Control Agents"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000018931",
                "InterventionAncestorTerm":"Antineoplastic Agents, Hormonal"
              },{
                "InterventionAncestorId":"D000000970",
                "InterventionAncestorTerm":"Antineoplastic Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M17673",
                "InterventionBrowseLeafName":"Leuprolide",
                "InterventionBrowseLeafAsFound":"Eligard",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M19550",
                "InterventionBrowseLeafName":"Antineoplastic Agents, Hormonal",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"ANeo",
                "InterventionBrowseBranchName":"Antineoplastic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"Repr",
                "InterventionBrowseBranchName":"Reproductive Control Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000011471",
                "ConditionMeshTerm":"Prostatic Neoplasms"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000005834",
                "ConditionAncestorTerm":"Genital Neoplasms, Male"
              },{
                "ConditionAncestorId":"D000014565",
                "ConditionAncestorTerm":"Urogenital Neoplasms"
              },{
                "ConditionAncestorId":"D000009371",
                "ConditionAncestorTerm":"Neoplasms by Site"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000005832",
                "ConditionAncestorTerm":"Genital Diseases, Male"
              },{
                "ConditionAncestorId":"D000011469",
                "ConditionAncestorTerm":"Prostatic Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M12918",
                "ConditionBrowseLeafName":"Prostatic Neoplasms",
                "ConditionBrowseLeafAsFound":"Prostate Cancer",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M7529",
                "ConditionBrowseLeafName":"Genital Neoplasms, Male",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15898",
                "ConditionBrowseLeafName":"Urogenital Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7527",
                "ConditionBrowseLeafName":"Genital Diseases, Male",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M12916",
                "ConditionBrowseLeafName":"Prostatic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}