{ "FullStudy":{ "Rank":217740, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517451", "OrgStudyIdInfo":{ "OrgStudyId":"J11157" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"NA_00067963", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"JHMIRB" } ] }, "Organization":{ "OrgFullName":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "OrgClass":"OTHER" }, "BriefTitle":"Radiation and Androgen Ablation for Prostate Cancer", "OfficialTitle":"Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate" }, "StatusModule":{ "StatusVerifiedDate":"November 2019", "OverallStatus":"Active, not recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 22, 2013", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 22, 2021", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"May 22, 2023", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 20, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 22, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"November 26, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"A study to see how effective and tolerable radiation therapy along with androgen deprivation therapy is in treating prostate cancer.", "DetailedDescription":"This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Adenocarcinoma of the Prostate" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1", "Phase 2" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"105", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Radiation with Androgen Deprivation Therapy (ADT)", "ArmGroupType":"Experimental", "ArmGroupDescription":"This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Radiation: Radiation Therapy", "Drug: Androgen Deprivation Therapy (ADT)" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Radiation", "InterventionName":"Radiation Therapy", "InterventionDescription":"7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Radiation with Androgen Deprivation Therapy (ADT)" ] } },{ "InterventionType":"Drug", "InterventionName":"Androgen Deprivation Therapy (ADT)", "InterventionDescription":"Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Radiation with Androgen Deprivation Therapy (ADT)" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Biochemical failure free-rate", "PrimaryOutcomeDescription":"To assess 5-year biochemical failure free rate (BFFR) associated with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently.", "PrimaryOutcomeTimeFrame":"1, 2, 3, 6 12, 18. 24, 30, 36 mont, 4 year and 5 year follow-up points after treatment has been completed" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Various Control Rate Assessments", "SecondaryOutcomeDescription":"Assess biochemical, clinical, and pathologic control rates associated with the combined hypofractionated dose regimen and ADT.", "SecondaryOutcomeTimeFrame":"1 year" },{ "SecondaryOutcomeMeasure":"Dose Volume/ Imaging Data Assessments", "SecondaryOutcomeDescription":"Collect dose/volume and imaging data to allow normal tissue complication probability modeling and targeting assessment for patients treated with hypofractionated radiation therapy.", "SecondaryOutcomeTimeFrame":"1 year" },{ "SecondaryOutcomeMeasure":"Biomarker Studies", "SecondaryOutcomeDescription":"Collect whole blood to perform correlative studies for serum cytokine profiling and future biomarker studies.", "SecondaryOutcomeTimeFrame":"1 year" },{ "SecondaryOutcomeMeasure":"Gastrointestinal (GI) and Genitourinary (GU toxicity) assessment", "SecondaryOutcomeDescription":"1) Assess the incidence of grade 3 or greater GU (genitourinary) and GI (gastrointestinal) toxicity with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently.", "SecondaryOutcomeTimeFrame":"1 year" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nHistologically confirmed, locally confined adenocarcinoma of the prostate\nPatient must fit D'Amico intermediate risk criteria by clinical stage (T2b-T2c), PSA (prostatic specific antigen) (10-20 ng/mL), and/or Gleason score (Gleason 7).\nThe patient has decided to undergo external beam radiation as treatment choice for his prostate cancer.\nSigned study-specific consent form prior to registration\n\nExclusion Criteria:\n\nStage T3-4 disease.\nGleason 8 or higher score.\nPSA > 20 ng/ml.\nIPSS (International Prostate Symptom Score) > 15\nClinical or Pathological Lymph node involvement (N1).\nEvidence of distant metastases (M1).\nRadical surgery for carcinoma of the prostate.\nPrevious Chemotherapy, unless intervention was greater than 5 years from beginning treatment for current prostate cancer.\nPrevious pelvic radiation therapy.\nPrevious or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years.\nHistory of inflammatory bowel disease.\nMajor medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.\nMyocardial infarction or cerebrovascular accident within one year from consultation, or other major vascular risk factor which would prevent a patient from receiving appropriate androgen deprivation therapy.11\nLiver function tests (LFTs) greater than twice the upper limit of normal.", "HealthyVolunteers":"No", "Gender":"Male", "MinimumAge":"18 Years", "MaximumAge":"100 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Phuoc Tran, M.D.", "OverallOfficialAffiliation":"Johns Hopkins University", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Sibley Memorial Hospital", "LocationCity":"Washington", "LocationState":"District of Columbia", "LocationZip":"20016", "LocationCountry":"United States" },{ "LocationFacility":"The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LocationCity":"Baltimore", "LocationState":"Maryland", "LocationZip":"21231", "LocationCountry":"United States" },{ "LocationFacility":"Suburban Hospital", "LocationCity":"Bethesda", "LocationState":"Maryland", "LocationZip":"20814", "LocationCountry":"United States" } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"Undecided" } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000000728", "InterventionMeshTerm":"Androgens" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000006728", "InterventionAncestorTerm":"Hormones" },{ "InterventionAncestorId":"D000006730", "InterventionAncestorTerm":"Hormones, Hormone Substitutes, and Hormone Antagonists" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M2640", "InterventionBrowseLeafName":"Androgens", "InterventionBrowseLeafAsFound":"Androgen", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M8372", "InterventionBrowseLeafName":"Hormones", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8371", "InterventionBrowseLeafName":"Hormone Antagonists", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000000230", "ConditionMeshTerm":"Adenocarcinoma" },{ "ConditionMeshId":"D000011471", "ConditionMeshTerm":"Prostatic Neoplasms" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000002277", "ConditionAncestorTerm":"Carcinoma" },{ "ConditionAncestorId":"D000009375", "ConditionAncestorTerm":"Neoplasms, Glandular and Epithelial" },{ "ConditionAncestorId":"D000009370", "ConditionAncestorTerm":"Neoplasms by Histologic Type" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000005834", "ConditionAncestorTerm":"Genital Neoplasms, Male" },{ "ConditionAncestorId":"D000014565", "ConditionAncestorTerm":"Urogenital Neoplasms" },{ "ConditionAncestorId":"D000009371", "ConditionAncestorTerm":"Neoplasms by Site" },{ "ConditionAncestorId":"D000005832", "ConditionAncestorTerm":"Genital Diseases, Male" },{ "ConditionAncestorId":"D000011469", "ConditionAncestorTerm":"Prostatic Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M12918", "ConditionBrowseLeafName":"Prostatic Neoplasms", "ConditionBrowseLeafAsFound":"Adenocarcinoma of the prostate", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M2166", "ConditionBrowseLeafName":"Adenocarcinoma", "ConditionBrowseLeafAsFound":"Adenocarcinoma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4116", "ConditionBrowseLeafName":"Carcinoma", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10903", "ConditionBrowseLeafName":"Neoplasms, Glandular and Epithelial", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10898", "ConditionBrowseLeafName":"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance":"low" },{ "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" } ] } } } } } }