[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580196":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":33,"locations":39,"responsibleParty":94,"collaborators":10,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":10,"enrollmentInfo":106,"targetDuration":10,"studyType":109,"phases":10,"briefSummary":110,"conditions":111,"keywords":116,"overallStatus":76,"whyStopped":10,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"University of Zurich","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pilot study",null,"For our pilot study, we assumed that around 3% of patients would have grade 3 acute urogenital toxicity (i.e. 1 patient). The rate of treatment discontinuation within 3 months was considered negligible. Our aim was to show with high probability, that the event rate was below a clinically acceptable threshold, which was set at 20%. Under the null hypothesis, this design with an alpha of 0.05 and power of 80% results in an expected number of cases of 30. Dropouts prior to treatment start will be replaced.",[13],"Radiation: radiotherapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Validation Cohort","For our validation study, we assume that around 3% of patients will have grade 3 long-term urogenital toxicity (i.e. 2 patients). The rate of treatment discontinuation within 3 months is considered negligible. Our aim is to show with high probability, that the event rate is below a clinically acceptable threshold, which is set at 12%. Under the null hypothesis, this design with an alpha of 0.05 and power of 80% results in an expected number of cases of 75. Dropouts prior to treatment start will be replaced.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"RADIATION","radiotherapy","Patients with prostate cancer in the medium or high risk range who are planned to receive definitive CT or MRI-adaptive SBRT.",[9,15],[25,28,31],{"name":26,"affiliation":5,"role":27},"Matthias Guckenberger, Prof. Dr. med.","STUDY_CHAIR",{"name":29,"affiliation":5,"role":30},"Tiuri E. Kroese, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":5,"role":30},"Matthias Guckenberger",[34],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},"Radiation Oncology Study Office","CONTACT","+41442554108","RAO_akademischesoffice@usz.ch",[40,59,74],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Klinik für Radioonkologie und Strahlentherapie, Universitätsklinikum Heidelberg","NOT_YET_RECRUITING","Heidelberg","Baden-Wurttemberg","69120","Germany","DE",{"type":49,"coordinates":50},"Point",[51,52],8.69079,49.40768,{"lat":52,"lon":51},[55,58],{"name":56,"role":36,"phone":10,"phoneExt":10,"email":57},"Jürgen Debus, Prof. Dr. med. Dr. rer. nat.","juergen.debus@med.uni-heidelberg.de",{"name":56,"role":30,"phone":10,"phoneExt":10,"email":10},{"facility":60,"status":42,"city":61,"state":62,"zip":63,"country":46,"countryCode":47,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Universitätsklinikum LMU","Munich","Bavaria","81377",{"type":49,"coordinates":65},[66,67],11.57549,48.13743,{"lat":67,"lon":66},[70,73],{"name":71,"role":36,"phone":10,"phoneExt":10,"email":72},"Claus Belka, Prof. Dr. med.","Claus.Belka@med.uni-muenchen.de",{"name":71,"role":30,"phone":10,"phoneExt":10,"email":10},{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"University Hospital Zurich, Department of Radio-Oncology","RECRUITING","Zurich","Canton of Zurich","8090","Switzerland","CH",{"type":49,"coordinates":83},[84,85],8.55,47.36667,{"lat":85,"lon":84},[88,91,93],{"name":26,"role":36,"phone":89,"phoneExt":10,"email":90},"+41 44 255 31 50","matthias.guckenberger@usz.ch",{"name":92,"role":30,"phone":10,"phoneExt":10,"email":10},"Tiuri E. Kroese, MD PhD",{"name":26,"role":30,"phone":10,"phoneExt":10,"email":10},{"type":95,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100580196","online-adaptive-stereotactic-body-radiotherapy-for-localized-prostate-cancer-x-smile-100580196",false,"NCT06834152","Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer (X-SMILE)","Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer in Patients With Lower Urinary Tract Symptoms and\u002For Prostate Hyperplasia (X-SMILE)","X-SMILE","Inclusion Criteria:\n\n* histologically confirmed localized prostate cancer\n* planned treatment is SBRT according to standard of care and consists of definitive CT or MRI online adaptive SBRT of the prostate according to the PACE trial which includes a total dose to clinical target volume 1 (CTV1, i.e. prostate and proximal 1 cm of the seminal vesicle) of 40.0 Gy in 5 weekly fractions (single dose of 8.0 Gy) and total dose to planning target volume 1 (PTV1) of 37.5 Gy in 5 weekly fractions (single dose of 7.5 Gy) with a compromise for bowel sparing allowed. For patients with unfavorable intermediate to very high-risk disease (according to NCCN guidelines) a total dose to the planning target volume 2 (PTV2, i.e. proximal 1-2 cm of the seminal vesicle) of 32.5 Gy in 5 weekly fractions (single dose of 6.5 Gy) will be delivered.\n* intermediate to (very) high risk localized prostate cancer (≤ cT3a and Gleason score ≤ 9 and\u002For PSA ≤ 20 ng\u002Fml)\n* prostate volume \\> 60 cc and\u002For IPSS \\> 12;\n\nExclusion Criteria:\n\n* Very high risk localized prostate cancer with indication for ADT and ARPI (i.e. Gleason ≥ 8 and cT3a)\n* Involvement of seminal vesicles (cT3b)\n* Contraindications against definitive CT or MRI-adaptive radiotherapy of the prostate, e.g. inflammatory bowel disease (IBD); previous radiotherapy in the pelvis, previous local radiotherapy of the prostate, contraindication for MRI or CT;\n* Patients with severe genitourinary symptoms (e.g. recent urinary retention ≥ grade 3 according CTCAE v.5.0);\n* Lymph node metastases or distant metastases (i.e. no localised prostate cancer);\n* Participation in a clinical trial which might influence the results of this project.","MALE","18 Years",{"count":107,"type":108},75,"ESTIMATED","OBSERVATIONAL","The aim of this phase II international multicenter study is to evaluate the safety, feasibility, and efficacy of CT or MRI-adaptive SBRT, delivered in five weekly fractions, in patients with newly diagnosed localized prostate cancer who have lower urinary tract symptoms and\u002For prostatic hyperplasia.",[112,113,114,115],"Localized Prostate Carcinoma","Prostate Cancer (Adenocarcinoma)","Prostate Hyperplasia","Lower Urinary Track Symptoms",[21,117,118,119,120,121,122,123,124],"SBRT","MRI","CT","stereotactic radiotherapy","localized prostate cancer","lower urinary tract symptoms","prostate hyperplasia","prostate cancer","2026-02-04",{"date":127,"type":128},"2026-02-09","ACTUAL",{"date":130,"type":128},"2024-03-01",{"date":132,"type":108},"2031-06-30",{"name":5,"class":6},3]