[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100466188":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":140,"collaborators":142,"id":157,"slug":25,"hasResults":158,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":25,"eligibilityCriteria":162,"healthyVolunteers":158,"sex":163,"minAge":164,"maxAge":25,"enrollmentInfo":165,"targetDuration":25,"studyType":168,"phases":169,"briefSummary":171,"conditions":172,"keywords":175,"overallStatus":60,"whyStopped":25,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},{"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",[41,58,73,87,100,113,128],{"facility":42,"status":43,"city":44,"state":45,"zip":25,"country":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Dept. of Oncology, Rigshospitalet, Denmark","NOT_YET_RECRUITING","Copenhagen","Capital Region","Denmark",{"type":48,"coordinates":49},"Point",[50,51],12.56553,55.67594,{"lat":51,"lon":50},[54],{"name":55,"role":37,"phone":56,"phoneExt":25,"email":57},"Peter Petersen, MD. Ph.D","+45 51260739","peter.meidahl.petersen@rh.regionh.dk",{"facility":59,"status":60,"city":61,"state":45,"zip":62,"country":46,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Department of Oncology, Copenhagen University Hospital Herlev","RECRUITING","Herlev","DK-2730 Herlev",{"type":48,"coordinates":64},[65,66],12.43998,55.72366,{"lat":66,"lon":65},[69],{"name":70,"role":37,"phone":71,"phoneExt":25,"email":72},"Henriette LIndberg, MD.Ph.D","+45 38689597","henriette.lindberg@regionh.dk",{"facility":74,"status":60,"city":75,"state":76,"zip":77,"country":46,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Department of Oncology, Aarhus University Hospital","Aarhus","Central Region","8200",{"type":48,"coordinates":79},[80,81],10.21076,56.15674,{"lat":81,"lon":80},[84],{"name":85,"role":37,"phone":25,"phoneExt":25,"email":86},"Anders Vittrup, MD. Ph.D","Anders.Schwartz.Vittrup@rm.dk",{"facility":88,"status":60,"city":89,"state":90,"zip":25,"country":46,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Dept. of Oncology, Aalborg University Hospital","Aalborg","Region North",{"type":48,"coordinates":92},[93,94],9.9187,57.048,{"lat":94,"lon":93},[97],{"name":98,"role":37,"phone":25,"phoneExt":25,"email":99},"Jimmi Søndergaard, MD, Ph.D","jiso@rn.dk",{"facility":101,"status":60,"city":102,"state":103,"zip":25,"country":46,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Dept. of Oncology, Zealand University Hospital, Denmark","Næstved","Region Sjælland",{"type":48,"coordinates":105},[106,107],11.76092,55.22992,{"lat":107,"lon":106},[110],{"name":111,"role":37,"phone":25,"phoneExt":25,"email":112},"Anne Juel Christensen, MD. Ph.D","anjc@regionsjaelland.dk",{"facility":114,"status":43,"city":115,"state":116,"zip":117,"country":46,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Department of Oncology, Odense University Hospital","Odense","Region South","5000",{"type":48,"coordinates":119},[120,121],10.38831,55.39594,{"lat":121,"lon":120},[124],{"name":125,"role":37,"phone":126,"phoneExt":25,"email":127},"Steinbjørn Hansen, MD.Ph.D","+45 6541 3988","steinbjoern.hansen@rsyd.dk",{"facility":129,"status":60,"city":130,"state":116,"zip":25,"country":46,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Department of Oncology, Vejle Hospital, Denmark","Vejle",{"type":48,"coordinates":132},[133,134],9.5357,55.70927,{"lat":134,"lon":133},[137],{"name":138,"role":37,"phone":25,"phoneExt":25,"email":139},"Christine Madsen, MD Ph.D","Christine.Vestergaard.Madsen@rsyd.dk",{"type":141,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[143,145,147,149,151,153,155],{"name":144,"class":6},"Rigshospitalet, Denmark",{"name":146,"class":6},"Odense University Hospital",{"name":148,"class":6},"Aarhus University Hospital",{"name":150,"class":6},"Aalborg University Hospital",{"name":152,"class":6},"Sygehus Lillebaelt",{"name":154,"class":6},"Herlev and Gentofte Hospital",{"name":156,"class":6},"Naestved Hospital","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":166,"type":167},400,"ESTIMATED","INTERVENTIONAL",[170],"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.",[173,174],"Prostate Cancer","Radiotherapy Side Effect",[176,177,178],"Proton Therapy","High Risk","Intensity Modulated Radiotherapy","2025-03-05",{"date":181,"type":182},"2025-03-07","ACTUAL",{"date":184,"type":182},"2022-03-01",{"date":186,"type":167},"2037-03-01",{"name":5,"class":6},7]