[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517844":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":54,"centralContacts":46,"locations":59,"responsibleParty":139,"collaborators":46,"id":141,"slug":46,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":46,"eligibilityCriteria":146,"healthyVolunteers":142,"sex":147,"minAge":148,"maxAge":46,"enrollmentInfo":149,"targetDuration":46,"studyType":152,"phases":153,"briefSummary":155,"conditions":156,"keywords":46,"overallStatus":61,"whyStopped":46,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"National Cancer Institute (NCI)","NIH",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm I (urolithin A)","EXPERIMENTAL","Patients receive urolithin A PO BID for 3-6 weeks prior to SOC RP. Patients also undergo biopsy at time of surgery and collection of blood samples during screening and on study.",[13,14,15],"Procedure: Biopsy Procedure","Procedure: Biospecimen Collection","Dietary Supplement: Urolithin A Supplement",{"label":17,"type":18,"description":19,"interventionNames":20},"Arm II (placebo)","PLACEBO_COMPARATOR","Patients receive placebo PO BID for 3-6 weeks prior to SOC RP. Patients also undergo biopsy at time of surgery and collection of blood samples during screening and on study.",[13,14,21],"Drug: Placebo Administration",[23,32,41,47],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"PROCEDURE","Biopsy Procedure","Undergo biopsy",[9,17],[29,30,31],"Biopsy","BIOPSY_TYPE","Bx",{"type":24,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Biospecimen Collection","Undergo collection of blood samples",[9,17],[37,38,39,40],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"DRUG","Placebo Administration","Given PO",[17],null,{"type":48,"name":49,"description":44,"armGroupLabels":50,"otherNames":51},"DIETARY_SUPPLEMENT","Urolithin A Supplement",[9],[52,53],"Mitopure","Uro-A Supplement",[55],{"name":56,"affiliation":57,"role":58},"Stephen J Freedland","Cedars-Sinai Medical Center","PRINCIPAL_INVESTIGATOR",[60,79,95,107,123],{"facility":57,"status":61,"city":62,"state":63,"zip":64,"country":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"RECRUITING","Los Angeles","California","90048","United States",{"type":67,"coordinates":68},"Point",[69,70],-118.24368,34.05223,{"lat":70,"lon":69},[73,78],{"name":74,"role":75,"phone":76,"phoneExt":46,"email":77},"Stephen J. Freedland","CONTACT","310-423-3974","Stephen.Freedland@cshs.org",{"name":74,"role":58,"phone":46,"phoneExt":46,"email":46},{"facility":80,"status":61,"city":81,"state":82,"zip":83,"country":65,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Northwestern University","Chicago","Illinois","60611",{"type":67,"coordinates":85},[86,87],-87.65005,41.85003,{"lat":87,"lon":86},[90,94],{"name":91,"role":75,"phone":92,"phoneExt":46,"email":93},"Ashley E. Ross","312-694-1117","ashley.ross1@northwestern.edu",{"name":91,"role":58,"phone":46,"phoneExt":46,"email":46},{"facility":96,"status":61,"city":81,"state":82,"zip":97,"country":65,"cosmosGeoPoint":98,"geoPoint":100,"contacts":101},"University of Chicago Comprehensive Cancer Center","60637",{"type":67,"coordinates":99},[86,87],{"lat":87,"lon":86},[102,106],{"name":103,"role":75,"phone":104,"phoneExt":46,"email":105},"Abhinav Sidana","773-702-1860","abhinav.sidana@bsd.uchicago.edu",{"name":103,"role":58,"phone":46,"phoneExt":46,"email":46},{"facility":108,"status":61,"city":109,"state":110,"zip":111,"country":65,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Duke University Medical Center","Durham","North Carolina","27710",{"type":67,"coordinates":113},[114,115],-78.89862,35.99403,{"lat":115,"lon":114},[118,122],{"name":119,"role":75,"phone":120,"phoneExt":46,"email":121},"Judd W. Moul","919-668-8108","judd.moul@duke.edu",{"name":119,"role":58,"phone":46,"phoneExt":46,"email":46},{"facility":124,"status":61,"city":125,"state":126,"zip":127,"country":65,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"University of Wisconsin Carbone Cancer Center - University Hospital","Madison","Wisconsin","53792",{"type":67,"coordinates":129},[130,131],-89.40123,43.07305,{"lat":131,"lon":130},[134,138],{"name":135,"role":75,"phone":136,"phoneExt":46,"email":137},"David F. Jarrard","608-262-0759","jarrard@urology.wisc.edu",{"name":135,"role":58,"phone":46,"phoneExt":46,"email":46},{"type":140,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100517844",false,"NCT06022822","Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial","A Phase 2 Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy","Inclusion Criteria:\n\n* Participants who have pathologically confirmed adenocarcinoma of the prostate with formalin-fixed paraffin embedded (FFPE) biopsy tissue available for analysis, including those on active surveillance. Most recent biopsy can be any time in the six months prior to registration\u002Frandomization\n* Participants \\>= 18 years will be enrolled. Because no dosing or adverse event (AE) data are currently available on the use of urolithin A in participants \\\u003C 18 years of age, children and adolescents are excluded from this study\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Participants on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible\n* Scheduled to undergo RP in the next 3-6 weeks\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Participants with prior primary treatment or hormonal therapy for prostate cancer (PC)\n* Participants with documented active alcohol and illegal substance dependency\n* Participants already receiving urolithin A (Mitopure, commercially available in the United States), or pomegranate supplements. Note: Other supplements are allowed but must be documented\n* Participants receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to urolithin A\n* Uncontrolled intercurrent illness, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements","MALE","18 Years",{"count":150,"type":151},90,"ESTIMATED","INTERVENTIONAL",[154],"PHASE2","This phase II randomized control trial assesses the effect of Urolithin A (Uro-A) supplementation compared to placebo in men with biopsy-confirmed prostate cancer undergoing radical prostatectomy (RP) progressive disease. A total of 90 men will be accrued and randomized 1:1 to receive a 1000 mg daily dose of Uro-A in two 250 mg capsules PO BID or two placebo capsules BID daily for 3 to 6 weeks prior to RP. The primary endpoint is to determine the effect of Uro-A on decreasing prostate tumor tissue oxidative stress (measured by 8-OHdG) compared to placebo.",[157],"Prostate Adenocarcinoma","2026-05-12",{"date":160,"type":161},"2026-05-13","ACTUAL",{"date":163,"type":161},"2024-09-12",{"date":165,"type":151},"2027-05-01",{"name":5,"class":6},5]