[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467941":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":30,"responsibleParty":63,"collaborators":20,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":20,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":20,"overallStatus":85,"whyStopped":20,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MR-guided hypofractionated focal boost radiotherapy","EXPERIMENTAL","External beam MR-guided (MR-linac) radiotherapy to the prostate and seminal vesicles of 5x7Gy (once weekly) with an isotoxic integrated focal boost up to 50Gy to the intraprostatic tumor as visible on multiparametric MR",[13],"Radiation: Ultrahypofractionated MR-guided radiotherapy boost",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","Ultrahypofractionated MR-guided radiotherapy boost","External beam MR-guided (MR-linac) radiotherapy to the prostate and seminal vesicles of 5x7Gy (once weekly) with an isotoxic integrated focal boost up to 50Gy to the intraprostatic tumor as visible on multiparametric MRI.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Casper Reijnen, MD, PhD","CONTACT","003124 361 4505","casper.reijnen@radboudumc.nl",{"name":28,"role":24,"phone":25,"phoneExt":20,"email":29},"Linda Kerkmeijer, MD, PhD","linda.kerkmeijer@radboudumc.nl",[31,48],{"facility":32,"status":20,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Radboudumc","Nijmegen","Gelderland","6525GA","Netherlands","NL",{"type":39,"coordinates":40},"Point",[41,42],5.85278,51.8425,{"lat":42,"lon":41},[45,47],{"name":28,"role":24,"phone":46,"phoneExt":20,"email":29},"+31243614505",{"name":23,"role":24,"phone":46,"phoneExt":20,"email":26},{"facility":49,"status":20,"city":50,"state":51,"zip":52,"country":36,"countryCode":37,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Netherlands Cancer Institute","Amsterdam","North Holland","1066CX",{"type":39,"coordinates":54},[55,56],4.88969,52.37403,{"lat":56,"lon":55},[59],{"name":60,"role":24,"phone":61,"phoneExt":20,"email":62},"Floris Pos, MD, PhD","+31205129111","f.pos@nki.nl",{"type":64,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100467941","phase-2-addition-of-a-focal-boost-in-external-beam-radiotherapy-for-locally-advanced-prostate-cancer-by-online-adaptive-mr-guided-radiotherapy-100467941",false,"NCT05373316","Addition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy","AFFIRM","Inclusion Criteria:\n\n* Men aged 18 years or older with histologically proven prostate carcinoma\n* Imaging stage T3b (as defined on mpMRI) N0M0\n* Intraprostatic lesion visible on MRI\n* Capable of giving informed consent\n\nExclusion Criteria:\n\n* History of radiotherapy to the pelvis or transurethral resection of the prostate (TURP)\n* Contraindications for MRI according to the guidelines of the local department of Radiology, inability to lay on a treatment table for 45-60 minutes or severe claustrophobia\n* Absence of pre-treatment PSMA PET CT\n* WHO performance score \\> 2\n* International Prostate Symptom Score ≥ 15\n* PSA \\> 30\n* Prostate volume \\>100c","MALE","18 Years","100 Years",{"count":76,"type":77},95,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","The AFFIRM trial tests the safety and clinical feasibility of MR-guided hypofractionated focal boost radiotherapy for patients with locally advanced prostate cancer. External beam radiotherapy combined with androgen deprivation therapy is considered as the treatment of choice for patients with locally advanced non-metastatic prostate cancer with seminal vesicle invasion.The long-term results of the multicentre phase III study (FLAME trial) showed that addition of an isotoxic focal boost to the intraprostatic lesion improves biochemical disease free survival in intermediate to high-risk patients without impacting toxicity and quality of life.\n\nThis focal boost strategy is now proven for a conventional fractionation scheme (35 fractions). The current trend in radiotherapy for prostate cancer is (extreme) hypofractionation, reducing the number of fractions. For locally advanced prostate cancer, however, the data on extreme hypofractionation are scarce.",[83,84],"Prostate Cancer","Prostate Neoplasm","NOT_YET_RECRUITING","2022-11-03",{"date":88,"type":89},"2022-11-07","ACTUAL",{"date":91,"type":77},"2022-12-01",{"date":93,"type":77},"2029-07-01",{"name":5,"class":6},2]