[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507226":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":39,"studyPopulation":39,"armGroups":46,"interventions":53,"overallOfficials":58,"centralContacts":63,"locations":69,"responsibleParty":88,"collaborators":39,"id":90,"slug":39,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":39,"studyType":102,"phases":103,"briefSummary":104,"conditions":105,"keywords":39,"overallStatus":71,"whyStopped":39,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"IRCCS Sacro Cuore Don Calabria di Negrar","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Acute gastrointestinal toxicity","Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and by patient-reported outcome according to the EPIC questionnaire. More specifically, acute toxicity will be defined as any gastrointestinal event occurred within 90 days from the RT treatment with grade ≥G2.","90 days from the RT treatment",[14,18,22,26,30,33,36],{"measure":15,"description":16,"timeFrame":17},"Acute genitourinary toxicity","Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0), and by patient-reported outcome according to the EPIC questionnaire. More specifically, acute toxicity will be defined as any genitourinary event occurred within 90 days from the RT treatment.","90 days from the RT treatment.",{"measure":19,"description":20,"timeFrame":21},"Late toxicity","Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0), and by patient-reported outcome according to the EPIC questionnaire. More specifically, late toxicity will be defined as any event (genitourinary and gastrointestinal) occurred from 90 days after the RT treatment.","From 90 days after the RT treatment until 24 months",{"measure":23,"description":24,"timeFrame":25},"QLQ-C30","Patient-reported outcomes will be assessed via the EORTC global (QLQ-C30) questionnaires at screening, 2nd and 4th week during RT, at 3, 6, 12, and 24 months","At screening, 2nd and 4th week during RT, at 3, 6, 12, and 24 months",{"measure":27,"description":28,"timeFrame":29},"Biochemical failure","PSA raise after RT from nadir","24 months",{"measure":31,"description":32,"timeFrame":29},"Time to biochemical failure","Time between salvage RT and biochemical failure",{"measure":34,"description":35,"timeFrame":29},"Local in-field relapse","Local in-field relapse evaluated with PET-CT or RM",{"measure":37,"description":38,"timeFrame":29},"Metastases-free survival","Metastases-free survival evaluated with PSMA PET-TC in case of PSA raise",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"NA","SINGLE_GROUP","TREATMENT",{"masking":45,"maskingDescription":39,"whoMasked":39},"NONE",[47],{"label":48,"type":49,"description":50,"interventionNames":51},"Treatment arm","EXPERIMENTAL","Patients will be treated on the prostate bed with Ethos using daily-adaptive modality with the dose of 59 Gy in 20 daily fractions of 2.95 Gy",[52],"Radiation: Daily Adaptive RadioTherapy",[54],{"type":55,"name":56,"description":50,"armGroupLabels":57,"otherNames":39},"RADIATION","Daily Adaptive RadioTherapy",[48],[59],{"name":60,"affiliation":61,"role":62},"Luca Nicosia","IRCCS Sacro Cuore Don Calabria - Dipartimento di Radioterapia Oncologica Avanzata","PRINCIPAL_INVESTIGATOR",[64],{"name":65,"role":66,"phone":67,"phoneExt":39,"email":68},"Elvia Malo","CONTACT","+390456014854","ricerca.clinica@sacrocuore.it",[70],{"facility":5,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"RECRUITING","Negrar","Verona","37024","Italy","IT",{"type":78,"coordinates":79},"Point",[80,81],10.93899,45.52918,{"lat":81,"lon":80},[84],{"name":85,"role":66,"phone":86,"phoneExt":39,"email":87},"Luca Nicosia, Doctor","+39(0)456014800","luca.nicosia@sacrocuore.it",{"type":89,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100507226",false,"NCT05884632","Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients","DART-PHASER","Inclusion Criteria:\n\n* Age ≤ 80 years;\n* Prostate cancer diagnosis, pT2-3 pN0, any resection margin (R0 or R1);\n* Indication to local salvage treatment defined as: early salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA \\\u003C0.2 ng\u002Fml or salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA ≥0.2 ng\u002Fml;\n* No distant metastases (M0) diagnosed with PSMA-PET-CT;\n* Informed consent to trial's participation and personal data treatment.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years old;\n* Adjuvant radiotherapy;\n* Previous radiation in the same anatomical site.","MALE","18 Years","80 Years",{"count":100,"type":101},184,"ESTIMATED","INTERVENTIONAL",[41],"This is a monoinstitutional prospective pilot study, aiming to evaluate treatment-related toxicity of an hypofractionated postoperative salvage radiotherapy with daily-adaptive modality in patients affected by prostate cancer biochemical recurrence.\n\nPatients will be treated with postoperative hypofractionated salvage radiotherapy with a dose of 59 Gy in 20 fractions with daily-adaptive modality. Considering the consolidate role and clinical outcome of postoperative hypofractionated radiotherapy with elevate level of evidence (8-10), the study will not be controlled, but compared with literature data.",[106],"Prostate Cancer","2023-05-23",{"date":109,"type":110},"2023-06-01","ACTUAL",{"date":112,"type":110},"2023-04-03",{"date":114,"type":101},"2030-04-30",{"name":5,"class":6},1]