[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526399":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":34,"locations":40,"responsibleParty":489,"collaborators":491,"id":498,"slug":499,"hasResults":500,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":500,"sex":506,"minAge":507,"maxAge":18,"enrollmentInfo":508,"targetDuration":18,"studyType":511,"phases":512,"briefSummary":514,"conditions":515,"keywords":517,"overallStatus":43,"whyStopped":18,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":532},{"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",[41,54,70,84,99,114,129,142,155,169,180,194,208,223,237,251,266,281,296,311,325,340,355,369,384,399,413,428,443,458,473],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":18,"geoPoint":18,"contacts":49},"Arizona Urology Specialists","RECRUITING","Tuscon","Arizona","85741","United States","US",[50],{"name":51,"role":37,"phone":52,"phoneExt":18,"email":53},"Kalpesh Patel, MD","520 618 1010","kpatel@arizonauro.com",{"facility":55,"status":43,"city":56,"state":57,"zip":58,"country":47,"countryCode":48,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"City of Hope - National Medical Center","Duarte","California","91010",{"type":60,"coordinates":61},"Point",[62,63],-117.97729,34.13945,{"lat":63,"lon":62},[66],{"name":67,"role":37,"phone":68,"phoneExt":18,"email":69},"Tanya Dorff Principal Investigator, 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Louis","Missouri","63141",{"type":60,"coordinates":287},[288,289],-90.19789,38.62727,{"lat":289,"lon":288},[292],{"name":293,"role":37,"phone":294,"phoneExt":18,"email":295},"Brittany Minor","314-806-3921","brittany.minor@objective.health",{"facility":297,"status":43,"city":298,"state":299,"zip":300,"country":47,"countryCode":48,"cosmosGeoPoint":301,"geoPoint":305,"contacts":306},"Integrated Medical Professionals","North Hills","New York","11040",{"type":60,"coordinates":302},[303,304],-73.67652,40.78093,{"lat":304,"lon":303},[307],{"name":308,"role":37,"phone":309,"phoneExt":18,"email":310},"Jed Kaminetsky, MD","212 480 3333","jkaminetsky@imppllc.com",{"facility":312,"status":43,"city":313,"state":299,"zip":314,"country":47,"countryCode":48,"cosmosGeoPoint":315,"geoPoint":319,"contacts":320},"Associated Medical Professionals of NY","Syracuse","13210",{"type":60,"coordinates":316},[317,318],-76.14742,43.04812,{"lat":318,"lon":317},[321],{"name":322,"role":37,"phone":323,"phoneExt":18,"email":324},"Christopher Pieczonka, MD","315 558 6619","cpieczonka@ampofny.com",{"facility":326,"status":43,"city":327,"state":328,"zip":329,"country":47,"countryCode":48,"cosmosGeoPoint":330,"geoPoint":334,"contacts":335},"Associated Urologists of North Carolina","Raleigh","North Carolina","27612",{"type":60,"coordinates":331},[332,333],-78.63861,35.7721,{"lat":333,"lon":332},[336],{"name":337,"role":37,"phone":338,"phoneExt":18,"email":339},"Mark Jalkut, MD","919 390 7368","mjalkut@gmail.com",{"facility":341,"status":43,"city":342,"state":343,"zip":344,"country":47,"countryCode":48,"cosmosGeoPoint":345,"geoPoint":349,"contacts":350},"The Urology Group","Cincinnati","Ohio","45212",{"type":60,"coordinates":346},[347,348],-84.51439,39.12711,{"lat":348,"lon":347},[351],{"name":352,"role":37,"phone":353,"phoneExt":18,"email":354},"Mark Pliskin, MD","513 841 7550","mpliskin@urologygroup.com",{"facility":356,"status":43,"city":357,"state":343,"zip":358,"country":47,"countryCode":48,"cosmosGeoPoint":359,"geoPoint":363,"contacts":364},"Central Ohio Urology Group","Gahanna","43230",{"type":60,"coordinates":360},[361,362],-82.87934,40.01923,{"lat":362,"lon":361},[365],{"name":366,"role":37,"phone":367,"phoneExt":18,"email":368},"Benjamin Martin, MD","614 396 2684","bmartin@centralohiourology.com",{"facility":370,"status":43,"city":371,"state":372,"zip":373,"country":47,"countryCode":48,"cosmosGeoPoint":374,"geoPoint":378,"contacts":379},"Oregon Urology Institute","Springfield","Oregon","97477",{"type":60,"coordinates":375},[376,377],-123.02203,44.04624,{"lat":377,"lon":376},[380],{"name":381,"role":37,"phone":382,"phoneExt":18,"email":383},"Bryan Mehlhaff, MD","541 284 5508","bryan@oregonurology.com",{"facility":385,"status":43,"city":386,"state":387,"zip":388,"country":47,"countryCode":48,"cosmosGeoPoint":389,"geoPoint":393,"contacts":394},"MidLantic Urology","Bala-Cynwyd","Pennsylvania","19004",{"type":60,"coordinates":390},[391,392],-75.23407,40.00761,{"lat":392,"lon":391},[395],{"name":396,"role":37,"phone":397,"phoneExt":18,"email":398},"Laurence Belkoff, MD","610 667 0458","lbelkoff@midlanticurology.com",{"facility":400,"status":43,"city":401,"state":387,"zip":402,"country":47,"countryCode":48,"cosmosGeoPoint":403,"geoPoint":407,"contacts":408},"Keystone Urology Specialists","Lancaster","17604",{"type":60,"coordinates":404},[405,406],-76.30551,40.03788,{"lat":406,"lon":405},[409],{"name":410,"role":37,"phone":411,"phoneExt":18,"email":412},"Paul Sieber, MD","717 431 2285","krisb@midlanticurology.com",{"facility":414,"status":43,"city":415,"state":416,"zip":417,"country":47,"countryCode":48,"cosmosGeoPoint":418,"geoPoint":422,"contacts":423},"Lowcountry Urology Institute","Charleston","South Carolina","29406",{"type":60,"coordinates":419},[420,421],-79.93275,32.77632,{"lat":421,"lon":420},[424],{"name":425,"role":37,"phone":426,"phoneExt":18,"email":427},"Justin Ellett, MD","843 572 1010","jellett@lcurology.com",{"facility":429,"status":43,"city":430,"state":416,"zip":431,"country":47,"countryCode":48,"cosmosGeoPoint":432,"geoPoint":436,"contacts":437},"Carolina Urologic Research Center, LLC","Myrtle Beach","29572",{"type":60,"coordinates":433},[434,435],-78.88669,33.68906,{"lat":435,"lon":434},[438],{"name":439,"role":37,"phone":440,"phoneExt":441,"email":442},"Neal Shore, MD","843-449-1010","5268","kate.valipour@startresearch.com",{"facility":444,"status":43,"city":445,"state":446,"zip":447,"country":47,"countryCode":48,"cosmosGeoPoint":448,"geoPoint":452,"contacts":453},"Urology Associates of Nashville","Nashville","Tennessee","37209",{"type":60,"coordinates":449},[450,451],-86.78444,36.16589,{"lat":451,"lon":450},[454],{"name":455,"role":37,"phone":456,"phoneExt":18,"email":457},"David Morris, MD","615-250-9268","ctrotter@ua-pc.com",{"facility":459,"status":43,"city":460,"state":461,"zip":462,"country":47,"countryCode":48,"cosmosGeoPoint":463,"geoPoint":467,"contacts":468},"Urology of Virginia","Virginia Beach","Virginia","23462",{"type":60,"coordinates":464},[465,466],-75.97799,36.85293,{"lat":466,"lon":465},[469],{"name":470,"role":37,"phone":471,"phoneExt":18,"email":472},"Robert Given, MD","757 452 3486","abohannon@urologyofva.net",{"facility":474,"status":43,"city":475,"state":476,"zip":477,"country":47,"countryCode":48,"cosmosGeoPoint":478,"geoPoint":482,"contacts":483},"Spokane Urology","Spokane","Washington","99202",{"type":60,"coordinates":479},[480,481],-117.42908,47.65966,{"lat":481,"lon":480},[484],{"name":485,"role":37,"phone":486,"phoneExt":487,"email":488},"Raymond Lance, MD","509 747 3147","112","Amyb@spokaneurology.com",{"type":490,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[492,495],{"name":493,"class":494},"WCG 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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":509,"type":510},400,"ESTIMATED","INTERVENTIONAL",[513],"PHASE2","A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).",[516],"Metastatic Castration-Resistant Prostate Cancer (mCRPC)",[518,519,520,521,522],"Single Dose","Sipuleucel-T","Immune Response Rate","Safety","Adenocarcinoma of the Prostate","2025-08-20",{"date":525,"type":526},"2025-08-27","ACTUAL",{"date":528,"type":526},"2023-10-02",{"date":530,"type":510},"2032-06-30",{"name":5,"class":6},31]