[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100344828":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":47,"responsibleParty":70,"collaborators":41,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":41,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":41,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":50,"whyStopped":41,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Curcumin","ACTIVE_COMPARATOR","* Other names for the supplement: BCM-95 CG (Biocurcumax),Tumeric\n* Manufacture- DolCas Biotech, LLC.\n* Classification - type of agent: Supplement\n* Protocol dose: 500 mg twice",[13],"Drug: Curcumin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Drug: placebo\n\nplacebo orally twice a day Other Names: •sugar pill",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Take medication one 500 mg pill of BCM-95 taken twice daily",[9],[26],"biocurcumax (BCM-95)",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Take medication one 500mg pill twice daily",[15],[31],"sugar pill",[33],{"name":34,"affiliation":5,"role":35},"Yair Lotan, MD","PRINCIPAL_INVESTIGATOR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Catherine Robinson","CONTACT","214-645-8103",null,"Catherine.Robinson@utsouthwestern.edu",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Maricruz Ibarra","214-645-8788","maricruz.ibarra@utsouthwestern.edu",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"UT Southwestern Medical Center","RECRUITING","Dallas","Texas","75390","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-96.80667,32.78306,{"lat":60,"lon":59},[63,66],{"name":34,"role":39,"phone":64,"phoneExt":41,"email":65},"214-645-8787","Yair.Lotan@utsouthwestern.edu",{"name":67,"role":39,"phone":68,"phoneExt":41,"email":69},"Jessica Williams","214-648-9195","Jessica.Williams2@utsouthwestern.edu",{"type":35,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"yair lotan","MD, Professor and Chief of Urologic Oncology","100344828","phase-3-trial-of-curcumin-to-prevent-progression-of-low-risk-prostate-cancer-under-active-surveillance-100344828",false,"NCT03769766","Trial of Curcumin to Prevent Progression of Low-risk Prostate Cancer Under Active Surveillance","A Randomized, Double-Blind, Placebo-Controlled Trial of Curcumin to Prevent Progression of Biopsy Proven, Low-risk Localized Prostate Cancer Patients Undergoing Active Surveillance","Inclusion Criteria:\n\n* Age between 40-89 years\n* Biopsy proven, low-risk, localized prostate cancer (minimum of 8 cores)\n* May have had biopsy within last 12 months\n* ≤4 separate locations in the prostate involved with cancer. If multiple cores are obtained from same lesion or area than this will count as one location.\n* Gleason score ≤6 with no Gleason pattern 4\n* Clinical stage T1c-T2a\u002Fb\n* Serum PSA ≤15 ng\u002Fml\n* Life expectancy \\> 5 years\n\nExclusion Criteria:\n\n* Any previous prostate cancer treatment (radiotherapy, chemotherapy, hormonal therapy, oral glucocorticoids, GnRH analogues, prostatectomy)\n* Concurrent or previous use within 6 months of screening of any 5α-reductase inhibitor\n* Use of anabolic steroids or drugs with antiandrogenic properties\n* Prostate volume \\>150 cm³\n* Patients who are taking antiplatelet, anticoagulant agents or have a history of a bleeding disorder. Patients taking 81 mg of Aspirin will be allowed to enroll with close observation\n* History of gastric or duodenal ulcers or untreated hyperacidity syndromes. Patients on stable doses (2 months of therapy) of GERD medication allowed.\n* Patients who are currently taking Curcumin and are unwilling to stop or plan to take Curcumin during the study\n* Patients with a history of gallbladder problems or gallstones or biliary obstruction, unless patient had cholecystectomy","MALE","40 Years","89 Years",{"count":84,"type":85},291,"ESTIMATED","INTERVENTIONAL",[88],"PHASE3","This is a prospective study to determine if the use of curcumin randomized against placebo will reduce cancer progression in patients with prostate cancer undergoing active surveillance.",[91],"Prostate Cancer",[93,94,95],"prostate cancer","active surveillance","curcumin","2026-06-11",{"date":98,"type":99},"2026-06-15","ACTUAL",{"date":101,"type":99},"2019-03-11",{"date":103,"type":85},"2030-11",{"name":5,"class":6},1]