[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526399":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":34,"locations":40,"responsibleParty":488,"collaborators":490,"id":497,"slug":18,"hasResults":498,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":498,"sex":504,"minAge":505,"maxAge":18,"enrollmentInfo":506,"targetDuration":18,"studyType":509,"phases":510,"briefSummary":512,"conditions":513,"keywords":515,"overallStatus":43,"whyStopped":18,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":530},{"fullName":5,"class":6},"Dendreon","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Booster Arm","EXPERIMENTAL","Experimental: Treatment Group: Single Infusion of Sipuleucel-T (Booster) Sipuleucel-T is an autologous cellular immunotherapy available as a suspension for intravenous infusion.\n\nSubjects randomized to sipuleucel-T arm will receive 1 infusion of sipuleucel-T 6-9 months after receiving commercial Provenge. These subjects will be followed as described in the schedule of events.",[13],"Drug: Sipuleucel-T Injection",{"label":15,"type":16,"description":17,"interventionNames":18},"No Booster","NO_INTERVENTION","No Intervention: Control Arm Subjects randomized to the control arm after receiving commercial Provenge will be followed as described in the schedule of events.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Sipuleucel-T Injection","Single Infusion",[9],[26,30],{"name":27,"affiliation":28,"role":29},"Nadeem Sheikh, PhD","Dendreon Pharmaceuticals, LLC","STUDY_DIRECTOR",{"name":31,"affiliation":32,"role":33},"Benjamin Lowentritt, MD","Chesapeake Urology","STUDY_CHAIR",[35],{"name":36,"role":37,"phone":38,"phoneExt":18,"email":39},"Margaret Warner-Lubin","CONTACT","2064588358","ProvONE@dendreon.com",[41,53,69,83,98,113,128,141,154,168,179,193,207,222,236,250,265,280,295,310,324,339,354,368,383,398,412,427,442,457,472],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"cosmosGeoPoint":18,"geoPoint":18,"contacts":48},"Arizona Urology Specialists","RECRUITING","Tuscon","Arizona","85741","United States",[49],{"name":50,"role":37,"phone":51,"phoneExt":18,"email":52},"Kalpesh Patel, MD","520 618 1010","kpatel@arizonauro.com",{"facility":54,"status":43,"city":55,"state":56,"zip":57,"country":47,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"City of Hope - National Medical Center","Duarte","California","91010",{"type":59,"coordinates":60},"Point",[61,62],-117.97729,34.13945,{"lat":62,"lon":61},[65],{"name":66,"role":37,"phone":67,"phoneExt":18,"email":68},"Tanya Dorff Principal Investigator, 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Urology","Lakewood","Colorado","80228",{"type":59,"coordinates":104},[105,106],-105.08137,39.70471,{"lat":106,"lon":105},[109],{"name":110,"role":37,"phone":111,"phoneExt":18,"email":112},"David Cahn, MD","303-996-9649","dcahn@coloradouro.com",{"facility":114,"status":43,"city":115,"state":116,"zip":117,"country":47,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Advanced Urology Institute","Daytona Beach","Florida","32114",{"type":59,"coordinates":119},[120,121],-81.02283,29.21081,{"lat":121,"lon":120},[124],{"name":125,"role":37,"phone":126,"phoneExt":18,"email":127},"Evan Fynes, MD","386 239 8500","Evan.fynes@auihealth.com",{"facility":114,"status":43,"city":129,"state":116,"zip":130,"country":47,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Largo","33771",{"type":59,"coordinates":132},[133,134],-82.78842,27.90979,{"lat":134,"lon":133},[137],{"name":138,"role":37,"phone":139,"phoneExt":18,"email":140},"Matthew Truesdale, MD","813 245 3782","matthew.truesdale@auihealth.com",{"facility":114,"status":43,"city":142,"state":116,"zip":143,"country":47,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Ocala","34471",{"type":59,"coordinates":145},[146,147],-82.14009,29.1872,{"lat":147,"lon":146},[150],{"name":151,"role":37,"phone":152,"phoneExt":18,"email":153},"Edward King, MD","352 430 0705","edward.king@auihealth.com",{"facility":155,"status":43,"city":156,"state":116,"zip":157,"country":47,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Florida Urology Partners","Riverview","33578",{"type":59,"coordinates":159},[160,161],-82.32648,27.86614,{"lat":161,"lon":160},[164],{"name":165,"role":37,"phone":166,"phoneExt":18,"email":167},"Alexander Engelman, MD","813-981-3931","aengelman@floridaurologypartners.com",{"facility":169,"status":170,"city":171,"state":172,"zip":173,"country":47,"cosmosGeoPoint":174,"geoPoint":178,"contacts":18},"Associated Urological Specialists","ACTIVE_NOT_RECRUITING","Chicago Ridge","Illinois","60415",{"type":59,"coordinates":175},[176,177],-87.77922,41.70142,{"lat":177,"lon":176},{"facility":180,"status":43,"city":181,"state":172,"zip":182,"country":47,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"UroPartners","Glenview","60026",{"type":59,"coordinates":184},[185,186],-87.78784,42.06975,{"lat":186,"lon":185},[189],{"name":190,"role":37,"phone":191,"phoneExt":18,"email":192},"Jeffrey Pearl, MD","847-823-3185","jpearl@uropartners.com",{"facility":194,"status":43,"city":195,"state":172,"zip":196,"country":47,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Advanced Urology Associates","New Lenox","60451",{"type":59,"coordinates":198},[199,200],-87.96561,41.51198,{"lat":200,"lon":199},[203],{"name":204,"role":37,"phone":205,"phoneExt":18,"email":206},"Greg Andros, MD","815 409 4930","DrAndros@advuro.com",{"facility":208,"status":43,"city":209,"state":210,"zip":211,"country":47,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Urology of Indiana","Carmel","Indiana","46032",{"type":59,"coordinates":213},[214,215],-86.11804,39.97837,{"lat":215,"lon":214},[218],{"name":219,"role":37,"phone":220,"phoneExt":18,"email":221},"Kenneth Ney, MD","317 564 5159","kney@urologyin.com",{"facility":223,"status":43,"city":224,"state":210,"zip":225,"country":47,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"First Urology","Jeffersonville","47130",{"type":59,"coordinates":227},[228,229],-85.73718,38.27757,{"lat":229,"lon":228},[232],{"name":233,"role":37,"phone":234,"phoneExt":18,"email":235},"Ryan Malone, MD","812-670-2755","rmalone@1sturology.com",{"facility":237,"status":43,"city":238,"state":210,"zip":239,"country":47,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Urologic Specialists of Northwest Indiana","Merrillville","46410",{"type":59,"coordinates":241},[242,243],-87.33281,41.48281,{"lat":243,"lon":242},[246],{"name":247,"role":37,"phone":248,"phoneExt":18,"email":249},"Manoj Rao, MD","219 259 1291","mrao@urologic-specialists.com",{"facility":251,"status":43,"city":252,"state":253,"zip":254,"country":47,"cosmosGeoPoint":255,"geoPoint":259,"contacts":260},"Chesapeake Urology Research Associates","Towson","Maryland","21204",{"type":59,"coordinates":256},[257,258],-76.60191,39.4015,{"lat":258,"lon":257},[261],{"name":262,"role":37,"phone":263,"phoneExt":18,"email":264},"Ronald Tutrone, MD","443 471 5741","rtutrone@uniteduro.com",{"facility":266,"status":43,"city":267,"state":268,"zip":269,"country":47,"cosmosGeoPoint":270,"geoPoint":274,"contacts":275},"Michigan Institute of Urology","Troy","Michigan","48084",{"type":59,"coordinates":271},[272,273],-83.14993,42.60559,{"lat":273,"lon":272},[276],{"name":277,"role":37,"phone":278,"phoneExt":18,"email":279},"Jason Hafron, MD","248 786 0467","hafronj@michiganurology.com",{"facility":281,"status":43,"city":282,"state":283,"zip":284,"country":47,"cosmosGeoPoint":285,"geoPoint":289,"contacts":290},"Specialty Clinical Research of St. Louis","St Louis","Missouri","63141",{"type":59,"coordinates":286},[287,288],-90.19789,38.62727,{"lat":288,"lon":287},[291],{"name":292,"role":37,"phone":293,"phoneExt":18,"email":294},"Brittany Minor","314-806-3921","brittany.minor@objective.health",{"facility":296,"status":43,"city":297,"state":298,"zip":299,"country":47,"cosmosGeoPoint":300,"geoPoint":304,"contacts":305},"Integrated Medical Professionals","North Hills","New York","11040",{"type":59,"coordinates":301},[302,303],-73.67652,40.78093,{"lat":303,"lon":302},[306],{"name":307,"role":37,"phone":308,"phoneExt":18,"email":309},"Jed Kaminetsky, MD","212 480 3333","jkaminetsky@imppllc.com",{"facility":311,"status":43,"city":312,"state":298,"zip":313,"country":47,"cosmosGeoPoint":314,"geoPoint":318,"contacts":319},"Associated Medical Professionals of NY","Syracuse","13210",{"type":59,"coordinates":315},[316,317],-76.14742,43.04812,{"lat":317,"lon":316},[320],{"name":321,"role":37,"phone":322,"phoneExt":18,"email":323},"Christopher Pieczonka, MD","315 558 6619","cpieczonka@ampofny.com",{"facility":325,"status":43,"city":326,"state":327,"zip":328,"country":47,"cosmosGeoPoint":329,"geoPoint":333,"contacts":334},"Associated Urologists of North Carolina","Raleigh","North Carolina","27612",{"type":59,"coordinates":330},[331,332],-78.63861,35.7721,{"lat":332,"lon":331},[335],{"name":336,"role":37,"phone":337,"phoneExt":18,"email":338},"Mark Jalkut, MD","919 390 7368","mjalkut@gmail.com",{"facility":340,"status":43,"city":341,"state":342,"zip":343,"country":47,"cosmosGeoPoint":344,"geoPoint":348,"contacts":349},"The Urology Group","Cincinnati","Ohio","45212",{"type":59,"coordinates":345},[346,347],-84.51439,39.12711,{"lat":347,"lon":346},[350],{"name":351,"role":37,"phone":352,"phoneExt":18,"email":353},"Mark Pliskin, MD","513 841 7550","mpliskin@urologygroup.com",{"facility":355,"status":43,"city":356,"state":342,"zip":357,"country":47,"cosmosGeoPoint":358,"geoPoint":362,"contacts":363},"Central Ohio Urology Group","Gahanna","43230",{"type":59,"coordinates":359},[360,361],-82.87934,40.01923,{"lat":361,"lon":360},[364],{"name":365,"role":37,"phone":366,"phoneExt":18,"email":367},"Benjamin Martin, MD","614 396 2684","bmartin@centralohiourology.com",{"facility":369,"status":43,"city":370,"state":371,"zip":372,"country":47,"cosmosGeoPoint":373,"geoPoint":377,"contacts":378},"Oregon Urology Institute","Springfield","Oregon","97477",{"type":59,"coordinates":374},[375,376],-123.02203,44.04624,{"lat":376,"lon":375},[379],{"name":380,"role":37,"phone":381,"phoneExt":18,"email":382},"Bryan Mehlhaff, MD","541 284 5508","bryan@oregonurology.com",{"facility":384,"status":43,"city":385,"state":386,"zip":387,"country":47,"cosmosGeoPoint":388,"geoPoint":392,"contacts":393},"MidLantic Urology","Bala-Cynwyd","Pennsylvania","19004",{"type":59,"coordinates":389},[390,391],-75.23407,40.00761,{"lat":391,"lon":390},[394],{"name":395,"role":37,"phone":396,"phoneExt":18,"email":397},"Laurence Belkoff, MD","610 667 0458","lbelkoff@midlanticurology.com",{"facility":399,"status":43,"city":400,"state":386,"zip":401,"country":47,"cosmosGeoPoint":402,"geoPoint":406,"contacts":407},"Keystone Urology Specialists","Lancaster","17604",{"type":59,"coordinates":403},[404,405],-76.30551,40.03788,{"lat":405,"lon":404},[408],{"name":409,"role":37,"phone":410,"phoneExt":18,"email":411},"Paul Sieber, MD","717 431 2285","krisb@midlanticurology.com",{"facility":413,"status":43,"city":414,"state":415,"zip":416,"country":47,"cosmosGeoPoint":417,"geoPoint":421,"contacts":422},"Lowcountry Urology Institute","Charleston","South Carolina","29406",{"type":59,"coordinates":418},[419,420],-79.93275,32.77632,{"lat":420,"lon":419},[423],{"name":424,"role":37,"phone":425,"phoneExt":18,"email":426},"Justin Ellett, MD","843 572 1010","jellett@lcurology.com",{"facility":428,"status":43,"city":429,"state":415,"zip":430,"country":47,"cosmosGeoPoint":431,"geoPoint":435,"contacts":436},"Carolina Urologic Research Center, LLC","Myrtle Beach","29572",{"type":59,"coordinates":432},[433,434],-78.88669,33.68906,{"lat":434,"lon":433},[437],{"name":438,"role":37,"phone":439,"phoneExt":440,"email":441},"Neal Shore, MD","843-449-1010","5268","kate.valipour@startresearch.com",{"facility":443,"status":43,"city":444,"state":445,"zip":446,"country":47,"cosmosGeoPoint":447,"geoPoint":451,"contacts":452},"Urology Associates of Nashville","Nashville","Tennessee","37209",{"type":59,"coordinates":448},[449,450],-86.78444,36.16589,{"lat":450,"lon":449},[453],{"name":454,"role":37,"phone":455,"phoneExt":18,"email":456},"David Morris, MD","615-250-9268","ctrotter@ua-pc.com",{"facility":458,"status":43,"city":459,"state":460,"zip":461,"country":47,"cosmosGeoPoint":462,"geoPoint":466,"contacts":467},"Urology of Virginia","Virginia Beach","Virginia","23462",{"type":59,"coordinates":463},[464,465],-75.97799,36.85293,{"lat":465,"lon":464},[468],{"name":469,"role":37,"phone":470,"phoneExt":18,"email":471},"Robert Given, MD","757 452 3486","abohannon@urologyofva.net",{"facility":473,"status":43,"city":474,"state":475,"zip":476,"country":47,"cosmosGeoPoint":477,"geoPoint":481,"contacts":482},"Spokane Urology","Spokane","Washington","99202",{"type":59,"coordinates":478},[479,480],-117.42908,47.65966,{"lat":480,"lon":479},[483],{"name":484,"role":37,"phone":485,"phoneExt":486,"email":487},"Raymond Lance, MD","509 747 3147","112","Amyb@spokaneurology.com",{"type":489,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[491,494],{"name":492,"class":493},"WCG IRB","OTHER",{"name":495,"class":496},"Talosix","UNKNOWN","100526399",false,"NCT06134232","Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T","An Open -Label, Multicenter Study of Subjects With Metastatic Castrate-Resistant Prostate Cancer Treated With PROVENGE ® and Boosted With A Single Infusion of Sipuleucel-T to Measure Immune Response","ProvONE","Inclusion Criteria:\n\nFor a subject to be eligible for participation in this study, all of the following criteria must be satisfied:\n\n1. Potential subjects are men aged ≥18 years who are clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \\[hormone refractory\\] prostate cancer).\n2. Have qualified for on-label PROVENGE® infusion\n3. Have received all 3 infusions of PROVENGE® prior to randomization\n4. Written informed consent provided prior to the initiation of study procedures\n5. Estimated life expectancy ≥12 months\n\nExclusion Criteria:\n\nA subject will not be eligible for participation in this study if any of the following criteria apply.\n\n1. Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \\[hormone refractory\\] prostate cancer).\n2. Need for systemic chronic immunosuppressive therapy, including antitumor necrosis factor alpha monoclonal antibodies, glucocorticoids, systemic steroids, blood products, GM-CSF or granulocyte colony-stimulating factor (G-CSF), any vaccinations, or experimental and investigational therapies (see Section 6.3.1)\n3. Uncontrolled, concurrent illness, including, but not limited to the following: ongoing or active infection (bacterial, viral, or fungal), or psychiatric illness that would limit compliance with study requirements, as well as any condition that would preclude a subject from completing PROVENGE® or sipuleucel-T treatment.\n4. On experimental or investigational therapy.","MALE","18 Years",{"count":507,"type":508},400,"ESTIMATED","INTERVENTIONAL",[511],"PHASE2","A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).",[514],"Metastatic Castration-Resistant Prostate Cancer (mCRPC)",[516,517,518,519,520],"Single Dose","Sipuleucel-T","Immune Response Rate","Safety","Adenocarcinoma of the Prostate","2025-08-20",{"date":523,"type":524},"2025-08-27","ACTUAL",{"date":526,"type":524},"2023-10-02",{"date":528,"type":508},"2032-06-30",{"name":5,"class":6},31]