Nctid:
NCT06616597
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D011471", "term"=>"Prostatic Neoplasms"}], "ancestors"=>[{"id"=>"D005834", "term"=>"Genital Neoplasms, Male"}, {"id"=>"D014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D005832", "term"=>"Genital Diseases, Male"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D011469", "term"=>"Prostatic Diseases"}, {"id"=>"D052801", "term"=>"Male Urogenital Diseases"}], "browseLeaves"=>[{"id"=>"M3585", "name"=>"Adenocarcinoma", "relevance"=>"LOW"}, {"id"=>"M14335", "name"=>"Prostatic Neoplasms", "asFound"=>"Prostate Cancer", "relevance"=>"HIGH"}, {"id"=>"M8946", "name"=>"Genital Neoplasms, Male", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M8944", "name"=>"Genital Diseases, Male", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14333", "name"=>"Prostatic Diseases", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D008795", "term"=>"Metronidazole"}, {"id"=>"D003907", "term"=>"Dexamethasone"}, {"id"=>"D000069501", "term"=>"Abiraterone Acetate"}], "ancestors"=>[{"id"=>"D000893", "term"=>"Anti-Inflammatory Agents"}, {"id"=>"D000932", "term"=>"Antiemetics"}, {"id"=>"D001337", "term"=>"Autonomic Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D005765", "term"=>"Gastrointestinal Agents"}, {"id"=>"D005938", "term"=>"Glucocorticoids"}, {"id"=>"D006728", "term"=>"Hormones"}, {"id"=>"D006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D018931", "term"=>"Antineoplastic Agents, Hormonal"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D000981", "term"=>"Antiprotozoal Agents"}, {"id"=>"D000977", "term"=>"Antiparasitic Agents"}, {"id"=>"D065088", "term"=>"Steroid Synthesis Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D006727", "term"=>"Hormone Antagonists"}, {"id"=>"D065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}], "browseLeaves"=>[{"id"=>"M7102", "name"=>"Dexamethasone", "asFound"=>"First", "relevance"=>"HIGH"}, {"id"=>"M4059", "name"=>"Androgens", "relevance"=>"LOW"}, {"id"=>"M11767", "name"=>"Metronidazole", "asFound"=>"0.1", "relevance"=>"HIGH"}, {"id"=>"M235549", "name"=>"Dexamethasone acetate", "relevance"=>"LOW"}, {"id"=>"M451", "name"=>"Abiraterone Acetate", "asFound"=>"Pharmacological", "relevance"=>"HIGH"}, {"id"=>"M4217", "name"=>"Anti-Inflammatory Agents", "relevance"=>"LOW"}, {"id"=>"M4251", "name"=>"Antiemetics", "relevance"=>"LOW"}, {"id"=>"M8881", "name"=>"Gastrointestinal Agents", "relevance"=>"LOW"}, {"id"=>"M9047", "name"=>"Glucocorticoids", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M20966", "name"=>"Antineoplastic Agents, Hormonal", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4298", "name"=>"Antiprotozoal Agents", "relevance"=>"LOW"}, {"id"=>"M4294", "name"=>"Antiparasitic Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Antiemetics", "abbrev"=>"AnEm"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>58}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2025-03-30", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-12", "completionDateStruct"=>{"date"=>"2032-03-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-12-10", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-12-11", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2031-03-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Number of participants with PSA30 response", "timeFrame"=>"24 weeks", "description"=>"Number of participants with castration resistant prostate cancer who have a ≥ 30% decline in PSA from baseline until 24 weeks."}], "secondaryOutcomes"=>[{"measure"=>"Number of participants with PSA50 response", "timeFrame"=>"12 weeks", "description"=>"Number of participants with castration resistant prostate cancer who have a ≥ 50% decline in PSA from baseline until 12 weeks."}, {"measure"=>"PSA Progression Free Survival", "timeFrame"=>"12 weeks", "description"=>"Number of participants with PSA progression according to PCWG3 (25% rise in PSA from nadir and increase of at least 2ng/mL)"}, {"measure"=>"Number of participants with progression", "timeFrame"=>"24 weeks", "description"=>"progression is defined as:\n\n* Progression of soft tissue lesions according to RECIST 1.1 Criteria.\n* Progression of bone lesions detected with bone scan according to PCWG3 criteria.\n* Radiologically-confirmed spinal cord compression or pathological fracture due to malignant progression, or other clinical event deemed to be cancer-related, or death."}, {"measure"=>"Number of grade 3-5 toxicities", "timeFrame"=>"24 weeks", "description"=>"Toxicity is evaluated based on current CTCAE standard grading scales."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Abiraterone", "microbiome", "Dexamethasone"], "conditions"=>["Prostate Cancer (Adenocarcinoma)", "Metastatic Prostate Cancer"]}, "descriptionModule"=>{"briefSummary"=>"To determine if dexamethasone or dexamethasone plus metronidazole restore sensitivity to abiraterone for the treatment of metastatic prostate cancer."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Males aged 18 years of age and above.\n* Prostate adenocarcinoma\n* Absolute PSA ≥ 2.0 ng/mL at screening.\n* PSA (+/- radiographic) progression after having been on abiraterone and prednisone for at least 12 weeks.\n* Must be maintained on a GnRH analogue or have undergone orchiectomy.\n* Participants must have a life expectancy ≥ 6 months\n* Ability to swallow study medication tablets\n* Willing to abstain from alcohol during and for 14 days after treatment with metronidazole\n* Willing and able to collect urine and stool samples per protocol\n\nExclusion Criteria:\n\n* Active infection or other medical condition that would make dexamethasone use contraindicated\n* Any chronic medical condition requiring a higher systemic dose of corticosteroid\n* Pathological finding consistent with small cell carcinoma of the prostate\n* Has imminent or established spinal cord compression based on clinical findings and/or MRI.\n* Chronic liver disease with Child-Pugh class C cirrhosis (see calculator in protocol)\n* Bilirubin \\>3x ULN or AST and ALT \\>5x ULN\n* Congenital prolonged QTc syndrome or QTc \\> 500 msec (non-paced rhythm)\n* History of pituitary or adrenal dysfunction\n* Uncontrolled diabetes (Hemoglobin A1c \\> 10%) or increasing doses of insulin within the past 4 weeks due to poorly controlled glucoses.\n* Administration of an investigational therapeutic or invasive surgical procedure (not including surgical castration) within 30 days of Cycle 1 Day 1 or currently enrolled in an investigational drug study\n* Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including, but not limited to:\n\n * Any uncontrolled major infection.\n * Crohn's disease or ulcerative colitis.\n * Known or suspected toxic megacolon and/or known small bowel ileus.\n * Known allergy to any of the compounds under investigation.\n* On antibacterial therapy within 30 days prior to administration of study treatment.\n* Any condition or situation which, in the opinion of the investigator, would put the subject at risk, or interfere with the subject's participation in this study."}, "identificationModule"=>{"nctId"=>"NCT06616597", "briefTitle"=>"Phase II Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer", "organization"=>{"class"=>"OTHER", "fullName"=>"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins"}, "officialTitle"=>"Phase II Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer", "orgStudyIdInfo"=>{"id"=>"J2485"}, "secondaryIdInfos"=>[{"id"=>"IRB00453879", "type"=>"OTHER", "domain"=>"JHM IRB"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Arm 1: Abiraterone + Dexamethasone", "description"=>"Abiraterone acetate plus dexamethasone", "interventionNames"=>["Drug: Abiraterone acetate", "Drug: Dexamethasone"]}, {"type"=>"EXPERIMENTAL", "label"=>"Arm 2: Abiraterone + Dexamethasone + metronidazole", "description"=>"Abiraterone acetate plus dexamethasone plus metronidazole", "interventionNames"=>["Drug: Abiraterone acetate", "Drug: Dexamethasone", "Drug: Metronidazole"]}], "interventions"=>[{"name"=>"Abiraterone acetate", "type"=>"DRUG", "description"=>"Abiraterone acetate 1000mg/ day", "armGroupLabels"=>["Arm 1: Abiraterone + Dexamethasone", "Arm 2: Abiraterone + Dexamethasone + metronidazole"]}, {"name"=>"Dexamethasone", "type"=>"DRUG", "description"=>"Dexamethasone 0.5mg/day", "armGroupLabels"=>["Arm 1: Abiraterone + Dexamethasone", "Arm 2: Abiraterone + Dexamethasone + metronidazole"]}, {"name"=>"Metronidazole", "type"=>"DRUG", "otherNames"=>["Flagyl"], "description"=>"Metronidazole 1500mg/ per day", "armGroupLabels"=>["Arm 2: Abiraterone + Dexamethasone + metronidazole"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20016", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "contacts"=>[{"name"=>"Layla Seward, RN", "role"=>"CONTACT", "email"=>"lseward1@jhmi.edu", "phone"=>"202-660-6500"}], "facility"=>"Sibley Memorial Hospital", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"21231", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "contacts"=>[{"name"=>"Irina Rifkind, RN", "role"=>"CONTACT", "email"=>"Irifkin1@jhmi.edu", "phone"=>"410-502-2043"}], "facility"=>"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}], "centralContacts"=>[{"name"=>"Irina Rifkind, RN", "role"=>"CONTACT", "email"=>"Irifkin1@jhmi.edu", "phone"=>"410-502-2043"}, {"name"=>"Sin Chan", "role"=>"CONTACT", "email"=>"schan44@jhmi.edu", "phone"=>"410-614-3630"}], "overallOfficials"=>[{"name"=>"Catherine Handy-Marshall, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Johns Hopkins University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
