[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100466188":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":141,"collaborators":143,"id":158,"slug":159,"hasResults":160,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":25,"eligibilityCriteria":164,"healthyVolunteers":160,"sex":165,"minAge":166,"maxAge":25,"enrollmentInfo":167,"targetDuration":25,"studyType":170,"phases":171,"briefSummary":173,"conditions":174,"keywords":177,"overallStatus":61,"whyStopped":25,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Proton therapy","EXPERIMENTAL","Radiation: Proton Therapy 78 Gray (Gy) in 39 fractions with 56 Gy to the Pelvic Lymph Nodes (LN), 5 days a week.\n\nAndrogen Deprivation Therapy (ADT) for three years, starting 3 months before Proton Therapy.",[13],"Radiation: Proton therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Photon Therapy","ACTIVE_COMPARATOR","Radiation: Photon Therapy 78 Gy in 39 fractions with 56 Gy to the pelvic LN, 5 days a week. ADT for three years, starting 3 months before Photon Therapy.",[19],"Radiation: Photon therapy",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","Patients in the experimental arm will receive proton therapy within the same dose and fraction schedule as patients receiving photon therapy, which is standard treatment.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Photon therapy","Patients in the photon arm will receive standard treatment with photon therapy.",[15],[31],{"name":32,"affiliation":33,"role":34},"Stine Elleberg Petersen, MD, Ph.D","Danish Centre for Particle Therapy, Aarhus University Hospital","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+4529474408","stinpete@rm.dk",[41,59,74,88,101,114,129],{"facility":42,"status":43,"city":44,"state":45,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Dept. of Oncology, Rigshospitalet, Denmark","NOT_YET_RECRUITING","Copenhagen","Capital Region","Denmark","DK",{"type":49,"coordinates":50},"Point",[51,52],12.56553,55.67594,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":57,"phoneExt":25,"email":58},"Peter Petersen, MD. Ph.D","+45 51260739","peter.meidahl.petersen@rh.regionh.dk",{"facility":60,"status":61,"city":62,"state":45,"zip":63,"country":46,"countryCode":47,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Department of Oncology, Copenhagen University Hospital Herlev","RECRUITING","Herlev","DK-2730 Herlev",{"type":49,"coordinates":65},[66,67],12.43998,55.72366,{"lat":67,"lon":66},[70],{"name":71,"role":37,"phone":72,"phoneExt":25,"email":73},"Henriette LIndberg, MD.Ph.D","+45 38689597","henriette.lindberg@regionh.dk",{"facility":75,"status":61,"city":76,"state":77,"zip":78,"country":46,"countryCode":47,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Department of Oncology, Aarhus University Hospital","Aarhus","Central Region","8200",{"type":49,"coordinates":80},[81,82],10.21076,56.15674,{"lat":82,"lon":81},[85],{"name":86,"role":37,"phone":25,"phoneExt":25,"email":87},"Anders Vittrup, MD. Ph.D","Anders.Schwartz.Vittrup@rm.dk",{"facility":89,"status":61,"city":90,"state":91,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Dept. of Oncology, Aalborg University Hospital","Aalborg","Region North",{"type":49,"coordinates":93},[94,95],9.9187,57.048,{"lat":95,"lon":94},[98],{"name":99,"role":37,"phone":25,"phoneExt":25,"email":100},"Jimmi Søndergaard, MD, Ph.D","jiso@rn.dk",{"facility":102,"status":61,"city":103,"state":104,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Dept. of Oncology, Zealand University Hospital, Denmark","Næstved","Region Sjælland",{"type":49,"coordinates":106},[107,108],11.76092,55.22992,{"lat":108,"lon":107},[111],{"name":112,"role":37,"phone":25,"phoneExt":25,"email":113},"Anne Juel Christensen, MD. Ph.D","anjc@regionsjaelland.dk",{"facility":115,"status":43,"city":116,"state":117,"zip":118,"country":46,"countryCode":47,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Department of Oncology, Odense University Hospital","Odense","Region South","5000",{"type":49,"coordinates":120},[121,122],10.38831,55.39594,{"lat":122,"lon":121},[125],{"name":126,"role":37,"phone":127,"phoneExt":25,"email":128},"Steinbjørn Hansen, MD.Ph.D","+45 6541 3988","steinbjoern.hansen@rsyd.dk",{"facility":130,"status":61,"city":131,"state":117,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Department of Oncology, Vejle Hospital, Denmark","Vejle",{"type":49,"coordinates":133},[134,135],9.5357,55.70927,{"lat":135,"lon":134},[138],{"name":139,"role":37,"phone":25,"phoneExt":25,"email":140},"Christine Madsen, MD Ph.D","Christine.Vestergaard.Madsen@rsyd.dk",{"type":142,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[144,146,148,150,152,154,156],{"name":145,"class":6},"Rigshospitalet, Denmark",{"name":147,"class":6},"Odense University Hospital",{"name":149,"class":6},"Aarhus University Hospital",{"name":151,"class":6},"Aalborg University Hospital",{"name":153,"class":6},"Sygehus Lillebaelt",{"name":155,"class":6},"Herlev and Gentofte Hospital",{"name":157,"class":6},"Naestved Hospital","100466188","protons-vs-photons-for-high-risk-prostate-cancer-100466188",false,"NCT05350475","Protons Vs. Photons for High-risk Prostate Cancer","Lymph Node Radiation Therapy with Integrated Boost to Prostate for High-risk Prostate Cancer a Randomized Phase 3 Trial Comparing Photons Vs. Protons","Inclusion Criteria:\n\n* Histologically verified localized\u002Flocally advanced prostate cancer T1-3bN0-1M0 (TNM 8th edition). A clinical T4 is allowed if it is because of invasion into the bladder neck.\n* Adenocarcinoma (mixed histology allowed as long as the adenocarcinoma component comprise more than 50%)\n* Indication for elective lymph node irradiation\n* PSA \\\u003C 100 ng\u002FmL\n* Age ≥18 years\n* Performance status 0-1\n* Life expectancy ≥ 10 years\n* Able to understand and comply with the treatment protocol\n* No evidence of inflammatory bowel disease Ability to adhere to procedures for study and follow-up\n* Signed informed consent to participate in the study\n\nExclusion Criteria:\n\n* No previous treatment for prostate cancer\n* Hip-prostheses\n* Other metal devices in the pelvic region (except fiducials)\n* Previous major abdominal\u002Frectal surgery\n* Any other malignancy the last five years except for basal or squamous cell skin cancer\n* Unable to understand patient information or comply with treatment and safety instructions\n* Unable to read and understand patient information due to cognitive disabilities or language (Danish).","MALE","18 Years",{"count":168,"type":169},400,"ESTIMATED","INTERVENTIONAL",[172],"NA","The purpose of this study is to assess late gastro-intestinal side-effects comparing proton therapy to photon therapy in high-risk prostate cancer patients receiving whole pelvic irradiation.",[175,176],"Prostate Cancer","Radiotherapy Side Effect",[178,179,180],"Proton Therapy","High Risk","Intensity Modulated Radiotherapy","2025-03-05",{"date":183,"type":184},"2025-03-07","ACTUAL",{"date":186,"type":184},"2022-03-01",{"date":188,"type":169},"2037-03-01",{"name":5,"class":6},7]