[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499706":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":70,"collaborators":40,"id":73,"slug":40,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":40,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":98,"overallStatus":48,"whyStopped":40,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"CHU de Quebec-Universite Laval","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ultra hypo fractionation radiation therapy","EXPERIMENTAL","comparative PRO's of 25 Gy in 5 daily fractions (Ultra hypo fractionation) administered to prostate and 1st centimeter of proximal seminal vesicle, starting mid week and ending mid following week.",[13],"Radiation: grade and compare reported side effects between groups",{"label":15,"type":16,"description":17,"interventionNames":18},"moderate hypo fractionation radiation therapy","ACTIVE_COMPARATOR","PRO's of moderate hypo fractionation, 37,5 Gy in 15 or 36 Gy in 12 daily fractions administered 5 days per week.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","grade and compare reported side effects between groups","Compare experimental ultra hypo fractionation (25 Gy in 5 daily fractions administered starting mid week and ending mid following week) to our standard fractionation (either 37,5 Gy given in 15 daily fractions, or 36 Gy in 12 daily fractions).\n\n* Toxicity analysis will be quantitatively evaluated using CTCAE (v5) at 1, 2 and 5 years post-therapy, and has needed at FU visits. Kaplan-Meier statistical analysis will be used to report toxicity evolution through time.\n* median IPSS scores will be reported at 3, 6, 12 months and yearly (1, 2, 3, 4 et 5) post-therapy. IPSS median time to baseline return will be calculated.\n* IPSS urinary scores, sexual function (SHIM) and GI toxicity (CTCAE-v5) and quality of life questionnaires ( EPIC-26) will be given at 3, 6 months and yearly thereafter (1, 2, 3, 4 et 5) post-treatment.",[15,9],[26,27,28,29,30],"report and compare IPSS scores","report and compare EPIC26 scores","report and compare SHIM scores","report and compare CTCAE scores","report and compare clinical outcomes",[32],{"name":33,"affiliation":34,"role":35},"Andre-Guy Martin","CHU de Québec","STUDY_CHAIR",[37,42],{"name":33,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","14186915264",null,"andre-guy.martin.med@ssss.gouv.qc.ca",{"name":43,"role":38,"phone":39,"phoneExt":40,"email":44},"Josee Allard","josee.allard@chudequebec.ca",[46],{"facility":47,"status":48,"city":49,"state":40,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"CHUdeQuebec","RECRUITING","Québec","G1R 2J6","Canada","CA",{"type":54,"coordinates":55},"Point",[56,57],-71.21454,46.81228,{"lat":57,"lon":56},[60,64,68],{"name":61,"role":38,"phone":62,"phoneExt":40,"email":63},"Andre-Guy Martin, MD,MSc,FRCPC","1-418-691-5264","Andre-Guy.Martin.med@ssss.gouv.qc.ca",{"name":65,"role":38,"phone":62,"phoneExt":66,"email":67},"Josée Allard, MSc","16730","Josee.Allard@chuq.qc.ca",{"name":61,"role":69,"phone":40,"phoneExt":40,"email":40},"PRINCIPAL_INVESTIGATOR",{"type":69,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"André-Guy Martin","Clinical professor, M.D., M.Sc., F.R.C.P.C.","100499706",false,"NCT05786742","Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.","ULTRA-HYPO Fractionated (UHF) Compared to Moderate-HYPO Fractionated (MHF) Prostate IGRT With HDR Brachytherapy BOOST : A Phase 1-2 Study.","HYPO-5","Inclusion Criteria:\n\n* Biopsy proven Prostate adenocarcinoma\n* Stage T1c, T2 (Annex 2)\n* Stage Nx or N0\n* Stage Mx or M0\n* PSA \\\u003C 20ng\u002Fml\n* Gleason Score 6 or 7\n* Having the ability to sing a written consent\n\nExclusion Criteria:\n\n* Age \\\u003C 18ans\n* Clinical Stage T3 or T4\n* Stage N1\n* Stage M1\n* PSA \\> 20\n* Gleason Score 8 to 10\n* IPSS Score \\> 20 alpha-blocking medication.\n* Prior pelvic radiotherapy.\n* History of active collagenosis (Lupus, Sclerodermia, Dermatomyosis)\n* Past history of Inflammatory Bowell Disease\n* Bilateral hip prosthesis",true,"MALE","18 Years","95 Years",{"count":85,"type":86},205,"ESTIMATED","INTERVENTIONAL",[89],"NA","Phase 1-2 study, comparing ultra-hypofractionnated (UH) to a moderately hypofractionnated (MH) radiation therapy, with image guided HDR prostate brachytherapy. Using iso-equivalent doses, a non-inferiority analysis will be done in order to prove UH non-inferior to MH, toxicity wise. Acceptability, tolerability, acute and late toxicity will be reported. MRI visible dominant intra-prostatic lesion will be outlines and variability between radiation oncologists and radiologists will be reported. As secondary objective, biochemical and clinical failure free survival will be reported at 5 \\& 10 years.",[92,93,94,95,96,97],"Prostate Cancer","Radiotherapy Side Effect","Hypofractionation","Brachytherapy","Radiotherapy","Localized Prostate Carcinoma",[99,100,101],"hypo fractionation","brachytherapy","Ultra Hypo fractionation","2025-09-07",{"date":104,"type":105},"2025-09-09","ACTUAL",{"date":107,"type":105},"2014-04",{"date":109,"type":86},"2033-12",{"name":5,"class":6},1]