[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06616597":3,"trial-entities:NCT06616597":132,"trial-summary:NCT06616597":136},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":49,"secondary_outcomes":54,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":71,"eligibility_criteria":72,"std_ages":102,"locations":105,"central_contacts":120,"overall_officials":125,"references":130,"see_also_links":131},"NCT06616597","J2485","Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer","Phase II Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer","RECRUITING","2032-03-30","2026-02","2026-02-19","2025-02-13","Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER",true,"To determine if dexamethasone or dexamethasone plus metronidazole restore sensitivity to abiraterone for the treatment of metastatic prostate cancer.","To test whether giving dexamethasone with or without metronidazole in combination with abiraterone could help reverse resistance to abiraterone for patients with metastatic castration-resistant prostate cancer (mCRPC). Abiraterone and prednisone (AA\u002FP) is a second-line therapy for mCRPC given when first-line androgen deprivation therapy fails. However, resistance to AA\u002FP can develop. The investigators do not know exactly how cancer becomes resistant, but there is evidence that suggests it could be due to androgen production by the bacteria in your gut (gut microbiome). This study is focused on the gut microbiome as a source of androgen production that could cause AA\u002FP resistance in mCRPC.",[19,20],"Prostate Cancer (Adenocarcinoma)","Metastatic Prostate Cancer",[22,23,24],"Abiraterone","microbiome","Dexamethasone","INTERVENTIONAL","TREATMENT",[28],"PHASE2",{"count":30,"type":31},58,"ESTIMATED",[33,40,43],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DRUG","Abiraterone acetate","Abiraterone acetate 1000mg\u002F day",[38,39],"Arm 1: Abiraterone + Dexamethasone","Arm 2: Abiraterone + Dexamethasone + metronidazole",{"type":34,"name":24,"description":41,"armGroupLabels":42},"Dexamethasone 0.5mg\u002Fday",[38,39],{"type":34,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Metronidazole","Metronidazole 1500mg\u002F per day",[39],[48],"Flagyl",[50],{"measure":51,"description":52,"timeFrame":53},"Number of participants with PSA30 response","Number of participants with castration resistant prostate cancer who have a ≥ 30% decline in PSA from baseline until 24 weeks.","24 weeks",[55,59,62,65],{"measure":56,"description":57,"timeFrame":58},"Number of participants with PSA50 response","Number of participants with castration resistant prostate cancer who have a ≥ 50% decline in PSA from baseline until 12 weeks.","12 weeks",{"measure":60,"description":61,"timeFrame":58},"PSA Progression Free Survival","Number of participants with PSA progression according to PCWG3 (25% rise in PSA from nadir and increase of at least 2ng\u002FmL)",{"measure":63,"description":64,"timeFrame":53},"Number of participants with progression","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":66,"description":67,"timeFrame":53},"Number of grade 3-5 toxicities","Toxicity is evaluated based on current CTCAE standard grading scales.","MALE","18 Years",null,false,{"inclusion":73,"exclusion":83,"raw_text":101},[74,75,76,77,78,79,80,81,82],"Males aged 18 years of age and above.","Prostate adenocarcinoma","Absolute PSA ≥ 2.0 ng\u002FmL at screening.","PSA (+\u002F- radiographic) progression after having been on abiraterone and prednisone for at least 12 weeks.","Must be maintained on a GnRH analogue or have undergone orchiectomy.","Participants must have a life expectancy ≥ 6 months","Ability to swallow study medication tablets","Willing to abstain from alcohol during and for 14 days after treatment with metronidazole","Willing and able to collect urine and stool samples per protocol",[84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100],"Active infection or other medical condition that would make dexamethasone use contraindicated","Any chronic medical condition requiring a higher systemic dose of corticosteroid","Pathological finding consistent with small cell carcinoma of the prostate","Has imminent or established spinal cord compression based on clinical findings and\u002For MRI.","Chronic liver disease with Child-Pugh class C cirrhosis (see calculator in protocol)","Bilirubin \\>3x ULN or AST and ALT \\>5x ULN","Congenital prolonged QTc syndrome or QTc \\> 500 msec (non-paced rhythm)","History of pituitary or adrenal dysfunction","Uncontrolled diabetes (Hemoglobin A1c \\> 10%) or increasing doses of insulin within the past 4 weeks due to poorly controlled glucoses.","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","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:","Any uncontrolled major infection.","Crohn's disease or ulcerative colitis.","Known or suspected toxic megacolon and\u002For known small bowel ileus.","Known allergy to any of the compounds under investigation.","On antibacterial therapy within 30 days prior to administration of study treatment.","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.","Inclusion Criteria:\n\n* Males aged 18 years of age and above.\n* Prostate adenocarcinoma\n* Absolute PSA ≥ 2.0 ng\u002FmL at screening.\n* PSA (+\u002F- 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\u002For 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\u002For 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.",[103,104],"ADULT","OLDER_ADULT",[106],{"facility":13,"status":8,"city":107,"state":108,"zip":109,"country":110,"contacts":111,"geoPoint":117},"Baltimore","Maryland","21231","United States",[112],{"name":113,"role":114,"phone":115,"email":116},"Irina Rifkind, RN","CONTACT","410-502-2043","Irifkin1@jhmi.edu",{"lat":118,"lon":119},39.29038,-76.61219,[121],{"name":122,"role":114,"phone":123,"email":124},"Donna Bieg, RN","410-502-7635","dieg2@jhmi.edu",[126],{"name":127,"affiliation":128,"role":129},"Catherine Handy Marshall, M.D.","Johns Hopkins University","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":133,"biomarkers":135},[134],"Prostate Carcinoma",[],{"nct_id":4,"found":15,"summary":137,"prompt_version":147},{"design":138,"status":139,"heading":140,"summary":141,"follow_up":142,"word_count":143,"commitments":144,"compensation":145,"drugs_mentioned":146},"This study plans to enroll 58 participants. It is an interventional study, meaning participants will receive specific treatments.","completed","Trial Targeting Gut Bacteria to Reverse Abiraterone Resistance in Metastatic Prostate Cancer","This study is for men with metastatic prostate cancer (cancer that has spread) whose abiraterone (a hormone therapy) treatment is no longer working. Researchers are testing if adding dexamethasone (a steroid) or dexamethasone plus metronidazole (an antibiotic) to your abiraterone treatment can make abiraterone effective again. The study aims to see if changing gut bacteria, which might be producing hormones that make the cancer resistant, can help. To join, you must be a man aged 18 or older with prostate cancer that has spread, a PSA (prostate-specific antigen) level of 2.0 ng\u002FmL or higher, and have experienced cancer progression while on abiraterone and prednisone for at least 12 weeks. The study will measure success by looking at how many participants have a 30% or more drop in their PSA levels after 24 weeks. The current recruitment status is unclear.","The primary endpoint is measured at 24 weeks, indicating follow-up for at least that duration.",139,"Not specified in the trial record.","Not stated in the trial record.",[24,44],"v2"]