[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547587":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":28,"studyPopulation":28,"armGroups":36,"interventions":47,"overallOfficials":28,"centralContacts":53,"locations":60,"responsibleParty":105,"collaborators":107,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":28,"enrollmentInfo":121,"targetDuration":28,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":28,"overallStatus":63,"whyStopped":28,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Rates of Acute Toxicity","Acute grade ≥2 gastrointestinal toxicity (CTCAE v5.0)","2 years",[14,17,20,22,25],{"measure":15,"description":16,"timeFrame":12},"Rates of Acute and Late Toxicity","Acute grade ≥2 genitourinary toxicity (CTCAE v5.0)",{"measure":18,"description":19,"timeFrame":12},"Quality of Life Outcomes","EPIC-26 Questionnaire",{"measure":18,"description":21,"timeFrame":12},"IPSS Questionnaire",{"measure":23,"description":24,"timeFrame":12},"Biochemical disease-free survival","Defined as survival until evidence of either biochemical progression (defined as a rise in prostate-specific antigen (PSA) ≥0.2ng\u002Fml above the PSA nadir followed by a sequentially equal or higher value) following postoperative radiotherapy, clinical or radiological progression, initiation of non-protocol systemic therapy, or death from prostate cancer",{"measure":26,"description":27,"timeFrame":12},"Disease Control Rate","Radiographic and\u002For histopathological disease control rate",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":32,"primaryPurpose":33,"observationalModel":28,"timePerspective":28,"maskingInfo":34},"RANDOMIZED","PARALLEL","Arm 1: External beam radiotherapy 54 Gy in 20 fractions to prostate bed +\u002F- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily.\n\nArm 2: External beam radiotherapy 30 Gy in 5 fractions to prostate bed +\u002F- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.","TREATMENT",{"masking":35,"maskingDescription":28,"whoMasked":28},"NONE",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"Arm 1: Moderately Hypofractionated Radiotherapy","EXPERIMENTAL","External beam radiotherapy 54 Gy in 20 fractions to prostate bed +\u002F- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily.",[42],"Radiation: Radiotherapy",{"label":44,"type":39,"description":45,"interventionNames":46},"Arm 2: Ultrahypofractionated Radiotherapy","External beam radiotherapy 30 Gy in 5 fractions to prostate bed +\u002F- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.",[42],[48],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":28},"RADIATION","Radiotherapy","Non-institutional-standard radiotherapy",[38,44],[54],{"name":55,"role":56,"phone":57,"phoneExt":58,"email":59},"Andrew McPartlin, MBChB","CONTACT","416-946-4501","4855","andrew.mcpartlin@uhn.ca",[61,80,96],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"London Health Sciences Centre","RECRUITING","London","Ontario","N6A 5W9","Canada","CA",{"type":70,"coordinates":71},"Point",[72,73],-81.23304,42.98339,{"lat":73,"lon":72},[76],{"name":77,"role":56,"phone":78,"phoneExt":28,"email":79},"Joelle Helou, MD","519-685-8650","joelle.helou@lhsc.on.ca",{"facility":81,"status":63,"city":82,"state":65,"zip":83,"country":67,"countryCode":68,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Sunnybrook Health Sciences Centre - Sunnybrook Research Institute","Toronto","M4N 3M5",{"type":70,"coordinates":85},[86,87],-79.39864,43.70643,{"lat":87,"lon":86},[90,94],{"name":91,"role":56,"phone":92,"phoneExt":28,"email":93},"Chia-Lin Tseng","416-480-4998","chia-lin.tseng@sunnybrook.ca",{"name":91,"role":95,"phone":28,"phoneExt":28,"email":28},"PRINCIPAL_INVESTIGATOR",{"facility":97,"status":63,"city":82,"state":65,"zip":98,"country":67,"countryCode":68,"cosmosGeoPoint":99,"geoPoint":101,"contacts":102},"University Health Network - Princess Margaret Cancer Centre","M5G 2C1",{"type":70,"coordinates":100},[86,87],{"lat":87,"lon":86},[103],{"name":104,"role":56,"phone":57,"phoneExt":58,"email":59},"Andrew McPartlin",{"type":106,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[108],{"name":109,"class":110},"TOLMAR PHARMACEUTIQUES CANADA, INC.","UNKNOWN","100547587","phase-2-comparing-moderately-ultra-hypofractionated-radiation-treatments-for-prostate-cancer-100547587",false,"NCT06409910","Comparing Moderately and Ultra Hypofractionated Radiation Treatments for Post-operative Prostate Cancer","A Phase II Randomized Trial: ALTERNATE DAY ULTRAHYPOFRACTIONATED OR DAILY MODERATELY HYPOFRACTIONATED POST OPERATIVE RADIOTHERAPY","AMPORA","Inclusion Criteria:\n\n1. Age \\>\u002F= 18 years\n2. Able to provide informed consent\n3. Histologic diagnosis of prostate adenocarcinoma\n4. ECOG performance status 0-1\n5. Previous radical prostatectomy \\> 6 months prior to radiotherapy start date\n6. Planned to receive post-operative radiation\n\nExclusion Criteria:\n\n1. Prior pelvic radiotherapy\n2. Contraindications to radiotherapy\n3. Confirmed metastases (if scan has been done for clinical care)\n4. Participants with visible disease in the prostate bed or pelvic lymph nodes on imaging are not eligible for treatment on study.","MALE","18 Years",{"count":122,"type":123},204,"ESTIMATED","INTERVENTIONAL",[126],"PHASE2","This is a multi-institution, randomized, non-inferiority Phase II trial comparing external beam radiotherapy delivered as 54 Gy in 20 fractions to prostate bed +\u002F- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily with external beam radiotherapy delivered as 30 Gy in 5 fractions to prostate bed +\u002F- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.",[129],"Post-Operative Prostate Cancer","2026-10-05",{"date":132,"type":133},"2026-10-08","ACTUAL",{"date":135,"type":133},"2024-11-26",{"date":137,"type":123},"2030-11",{"name":5,"class":6},3]