{
  "FullStudy":{
    "Rank":217785,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516866",
          "OrgStudyIdInfo":{
            "OrgStudyId":"CO11811"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"2011-0397",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"Institutional Review Board"
              },{
                "SecondaryId":"A534260",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"UW Madison"
              },{
                "SecondaryId":"SMPH\\MEDICINE\\HEM-ONC",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"UW Madison"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"University of Wisconsin, Madison",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC) With Microtubule Directed Chemo or AR-directed Therapy",
          "OfficialTitle":"NaF PET/CT Repeatability, Responsiveness, and Response Assessment in Patients With Metastatic Castrate-resistant Prostate Cancer to Bone Treated With Either an Antimicrotubule Directed Agent or Androgen Receptor (AR)-Directed Therapies",
          "Acronym":"NaFl PET/CT"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2018",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2011",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"September 2015",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"January 1, 2018",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"November 28, 2011",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"November 14, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"November 18, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of Wisconsin, Madison",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this research study is to evaluate a newer imaging technique, called 18F-Sodium Fluoride (NaF) positron emission tomography (PET). NaF is a tracer (dye) that is very sensitive for changes in bone. By using this tracer with positron emission tomography/computed tomography (PET/CT) imaging, our ability to evaluate and measure changes in bone lesions could be greatly improved.",
          "DetailedDescription":"The study will look at how repeatable the NaF PET scans are before treatment. Scans will also be performed after standard chemotherapy or hormone-directed treatment. This will allow evaluation of how the NaF PET scans change with the chemotherapy or hormone-directed therapy. In addition, NaF PET scans will be compared with standard computed tomography (CT) and bone scans, as well as prostate specific antigen (PSA). This information could be used to develop better ways to measure prostate cancer bone lesions. In turn, this could be used to better evaluate treatment effects of standard chemotherapy and other new drugs being developed to treat prostate cancer."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Prostate Cancer"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Androgen receptor-directed therapy",
              "NaF PET/CT",
              "antimicrotubule directed chemotherapy"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "PatientRegistry":"No",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case-Control"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"58",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Cohort A: Microtubule directed chemotherapy treatment",
                "ArmGroupDescription":"Subjects receiving antimicrotubule chemotherapy-based treatment will have NaF PET/CT scans at baseline and again after 8 weeks of starting treatment. A subset of subjects will have a second NaF PET/CT scan at baseline 1-8 days after the first baseline scan.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) imaging"
                  ]
                }
              },{
                "ArmGroupLabel":"Cohort B: AR-directed therapy",
                "ArmGroupDescription":"Subjects receiving AR-directed therapy will undergo a baseline NaF PET/CT scan at baseline and again after having been on treatment for 6 weeks and again at 12 weeks. A subset of subjects will also undergo a second baseline NaF PET/CT scan 1-8 days after the first baseline scan.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) imaging"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) imaging",
                "InterventionDescription":"Subjects who will be enrolled will be those who will be starting treatment (as part of standard of care or as part of another trial) with either a microtubule directed chemotherapy regimen (cohort A), or AR-directed therapy (cohort B). All subjects will have a baseline NaF PET/CT scan (baseline #1), performed within days prior to starting either chemotherapy or AR-directed therapy. A subset of subjects (up to 20 subjects per site, 60 total) will undergo a second NaF PET/CT scan (baseline #2) within 1-8 days of the initial scan to determine repeatability of NaF PET/CT scanning. Subjects in cohort A will undergo another NaF PET/CT scan at week 8 (+/- 1 week). Subjects in cohort B will undergo two additional NaF PET/CT scans at weeks 6 and 12 (+/- 1 week).",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Cohort A: Microtubule directed chemotherapy treatment",
                    "Cohort B: AR-directed therapy"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"The repeatability of NaF PET/CT imaging for evaluating bone metastases in patients with metastatic castrate-resistant prostate cancer.",
                "PrimaryOutcomeDescription":"NaF PET/CT scan will be performed within 14 days prior to starting chemotherapy (antimicrotubule directed chemotherapy) or hormone-directed therapy (baseline #1). A portion of subjects (up to 20 subjects at each site, 60 subjects total) will have a second NaF PET/CT scan performed (baseline #2) within 1-8 days of the initial scan to see if measurements repeated over a short period of time are similar.",
                "PrimaryOutcomeTimeFrame":"2 years"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Evaluate changes on NaF PET/CT images in response to chemotherapy (antimicrotubule directed chemotherapy) or androgen receptor (AR)-directed therapy.",
                "SecondaryOutcomeDescription":"All subjects will undergo NaF PET/CT scanning at baseline and again either 8 weeks after starting treatment with antimicrotubule chemotherapy based treatment (Cohort A) OR at both 6 weeks and 12 weeks after starting AR-directed treatment (Cohort B).",
                "SecondaryOutcomeTimeFrame":"2 years"
              },{
                "SecondaryOutcomeMeasure":"Prostate Specific Antigen (PSA) response",
                "SecondaryOutcomeDescription":"Results from the NaF PET/CT scans will be compared with PSA and bone scan and CT scan results.",
                "SecondaryOutcomeTimeFrame":"2 years"
              },{
                "SecondaryOutcomeMeasure":"Response Evaluation Criteria in Solid Tumors (RECIST) response",
                "SecondaryOutcomeTimeFrame":"2 years"
              },{
                "SecondaryOutcomeMeasure":"Radiographic progression free survival",
                "SecondaryOutcomeTimeFrame":"2 years"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nHistologically confirmed adenocarcinoma of the prostate\nIdentifiable prostate cancer-related bone metastases on bone scan in the spine, pelvis or other bone\nPatients must be starting a microtubule directed chemotherapy regimen for metastatic castrate-resistant prostate cancer OR\nPatients must be starting a AR-directed regimen (e.g. Abiraterone, MDV-3100, TAK-700, etc) for treatment of metastatic castrate-resistant prostate\n\nExclusion Criteria:\n\nConcurrent treatment with any other agent that is being used with the expressed purpose of treating of prostate cancer outside of the planned treatment regimen\nPatients who have received radiotherapy less than 4 weeks prior to registration.\nPatients who have received prior Strontium-89, Samarium-153, or other radioisotope.\nHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to sodium fluoride F-18 (NaF).",
          "HealthyVolunteers":"No",
          "Gender":"Male",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Primary care clinic",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Glenn Liu, MD",
                "OverallOfficialAffiliation":"University of Wisconsin, Madison",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Robert Jeraj, Ph.D.",
                "OverallOfficialAffiliation":"University of Wisconsin, Madison",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"National Cancer Institute",
                "LocationCity":"Bethesda",
                "LocationState":"Maryland",
                "LocationZip":"20892",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Memorial Sloan Kettering",
                "LocationCity":"New York",
                "LocationState":"New York",
                "LocationZip":"10065",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"University of Wisconsin Carbone Cancer Center",
                "LocationCity":"Madison",
                "LocationState":"Wisconsin",
                "LocationZip":"53792",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"University of Wisconsin Carbone Cancer Center",
                "SeeAlsoLinkURL":"https://cancer.wisc.edu/"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"C000057473",
                "InterventionMeshTerm":"Listerine"
              },{
                "InterventionMeshId":"D000005459",
                "InterventionMeshTerm":"Fluorides"
              },{
                "InterventionMeshId":"D000012969",
                "InterventionMeshTerm":"Sodium Fluoride"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000002327",
                "InterventionAncestorTerm":"Cariostatic Agents"
              },{
                "InterventionAncestorId":"D000020011",
                "InterventionAncestorTerm":"Protective Agents"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000000891",
                "InterventionAncestorTerm":"Anti-Infective Agents, Local"
              },{
                "InterventionAncestorId":"D000000890",
                "InterventionAncestorTerm":"Anti-Infective Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M143226",
                "InterventionBrowseLeafName":"Listerine",
                "InterventionBrowseLeafAsFound":"Sodium Fluoride (NaF)",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M7170",
                "InterventionBrowseLeafName":"Fluorides",
                "InterventionBrowseLeafAsFound":"Fluoride",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M14354",
                "InterventionBrowseLeafName":"Sodium Fluoride",
                "InterventionBrowseLeafAsFound":"Sodium fluoride",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M20453",
                "InterventionBrowseLeafName":"Protective Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2795",
                "InterventionBrowseLeafName":"Anti-Infective Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2796",
                "InterventionBrowseLeafName":"Anti-Infective Agents, Local",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Infe",
                "InterventionBrowseBranchName":"Anti-Infective 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"
              },{
                "ConditionBrowseLeafId":"T3227",
                "ConditionBrowseLeafName":"Kennedy Disease",
                "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"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}