[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556325":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":50,"studyPopulation":42,"armGroups":51,"interventions":64,"overallOfficials":42,"centralContacts":74,"locations":80,"responsibleParty":251,"collaborators":42,"id":253,"slug":42,"hasResults":254,"nctId":255,"briefTitle":256,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":254,"sex":259,"minAge":260,"maxAge":42,"enrollmentInfo":261,"targetDuration":42,"studyType":264,"phases":265,"briefSummary":267,"conditions":268,"keywords":42,"overallStatus":83,"whyStopped":42,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":279},{"fullName":5,"class":6},"Jules Bordet Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"SBRT impact on patient-reported GI and GU symptoms","Urinary and bowel domain of the EPIC-26 (Expanded Prostate Cancer Index Composite).","2 years post treatment",[14,18,22,26,30,33,36,39],{"measure":15,"description":16,"timeFrame":17},"Patient Reported Outcomes","Patient-reported outcomes according to the different\n\n* EPIC-26 domains (0-100)\n* IPSS score (0-35)\n* EQ-5D-5L scores (five dimensions: mobility, self-care, usual activities, pain\u002Fdiscomfort and anxiety\u002Fdepression)","at end of RT and following time-points counted from start of RT : 4-7 weeks (only in experimental arm), 3 months, 6 months, 1 year and yearly up to 5 years",{"measure":19,"description":20,"timeFrame":21},"Ccost-utility during radiotherapy","Cost-utility analysis based on EQ-5D-5L (five dimensions: mobility, self-care, usual activities, pain\u002Fdiscomfort and anxiety\u002Fdepression)versus costs of RT and transportation during radiotherapy","during radiotherapy",{"measure":23,"description":24,"timeFrame":25},"Physician-scored toxicity","Physician-scored toxicity according to CTCAE 5.0 (grades) (Early: within 90 days; or late: 90 or more days after SBRT). Proportion of patients with G2+ toxicity will be reported specifically.","up to 5 years",{"measure":27,"description":28,"timeFrame":29},"Blood lymphocyte evolution between study arms","Lymphocyte count nadir relative to baseline","5 years",{"measure":31,"description":32,"timeFrame":29},"To compare biochemical progression-free survival (bPFS) to historical control and between study arms","Biochemical progression-free survival (bPFS)",{"measure":34,"description":35,"timeFrame":29},"To compare local and regional recurrences between study arms, up to 5 years.","Local and regional control",{"measure":37,"description":38,"timeFrame":29},"To compare Overall survival (OS) between study arms, up to 5 years.","Overall survival (OS)",{"measure":40,"description":41,"timeFrame":29},"To compare distant metastases-free survival (dmFS) between study arms","Distant metastases-free survival (dmFS).",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":46,"primaryPurpose":47,"observationalModel":42,"timePerspective":42,"maskingInfo":48},"RANDOMIZED","PARALLEL","Non-inferiority randomized controlled trial","TREATMENT",{"masking":49,"maskingDescription":42,"whoMasked":42},"NONE","This is a multicentric randomized seamless phase II\u002FIII study comparing SBRT to conventional RT or moderately hypofractionated RT on the prostate bed.\n\nAll subjects will be randomly assigned in a 1:1 ratio:\n\n1. Experimental arm: Radiotherapy treatment in 5 fractions.\n2. Control arm: Radiotherapy treatment within a normofractionated or mildly hypofractionated schedule. For the control arm, each participating center can choose between a normofractionated schedule (32 to 35 treatment sessions) and a moderately hypofractionated schedule (20 sessions).",[52,58],{"label":53,"type":54,"description":55,"interventionNames":56},"Control","ACTIVE_COMPARATOR","Standard of care radiotherapy",[57],"Radiation: SOC RT",{"label":59,"type":60,"description":61,"interventionNames":62},"SBRT","EXPERIMENTAL","SBRT: 5 fractions",[63],"Radiation: Stereotactic body radiotherapy (SBRT)",[65,70],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":42},"RADIATION","Stereotactic body radiotherapy (SBRT)","5 fractions of SBRT to the prostate bed with or without whole pelvic radiotherapy Treatment every other day.",[59],{"type":66,"name":71,"description":72,"armGroupLabels":73,"otherNames":42},"SOC RT","Standard salvage radiotherapy to the prostate bed with or without whole pelvic radiotherapy. Each participating centre can specify upfront which RT schedule will be used in the control arm, with the choice between the following schedules:\n\n* Hypofractionated: 20 fractions (Daily treatment (OTT 4-5 weeks))\n* Normofractionated: 32-35 fractions (Daily treatment (OTT 7-8 weeks))",[53],[75],{"name":76,"role":77,"phone":78,"phoneExt":42,"email":79},"Robbe Van den Begin, MD, PhD","CONTACT","+3225413832","robbe.vandenbegin@hubruxelles.be",[81,98,111,124,135,148,160,173,186,199,212,225,238],{"facility":82,"status":83,"city":84,"state":42,"zip":42,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"AZorg","RECRUITING","Aalst","Belgium","BE",{"type":88,"coordinates":89},"Point",[90,91],4.0355,50.93604,{"lat":91,"lon":90},[94],{"name":95,"role":77,"phone":96,"phoneExt":42,"email":97},"Benedikt Engels, MD PhD","053 72 86 66","radiotherapie@azorg.be",{"facility":99,"status":83,"city":100,"state":42,"zip":42,"country":85,"countryCode":86,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Ziekenhuis Aan de Stroom (ZAS)","Antwerp",{"type":88,"coordinates":102},[103,104],4.40026,51.22047,{"lat":104,"lon":103},[107],{"name":108,"role":77,"phone":109,"phoneExt":42,"email":110},"Piet Dirix, MD PhD","03 443 37 37","gza.iridiumnetwerk@zas.be",{"facility":112,"status":83,"city":113,"state":42,"zip":42,"country":85,"countryCode":86,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"AZ Sint Jan","Bruges",{"type":88,"coordinates":115},[116,117],3.22424,51.20892,{"lat":117,"lon":116},[120],{"name":121,"role":77,"phone":122,"phoneExt":42,"email":123},"Sabine Meersschout, MD","+3250 45 28 00","radiotherapie.brugge@azsintjan.be",{"facility":125,"status":83,"city":126,"state":42,"zip":42,"country":85,"countryCode":86,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Jules Bordet Institute, H.U.B","Brussels",{"type":88,"coordinates":128},[129,130],4.34878,50.85045,{"lat":130,"lon":129},[133],{"name":134,"role":77,"phone":78,"phoneExt":42,"email":42},"Nicolas Jullian, MD",{"facility":136,"status":83,"city":137,"state":42,"zip":42,"country":85,"countryCode":86,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Ziekenhuis Oost-Limburg (ZOL) Campus Sint-Jan","Genk",{"type":88,"coordinates":139},[140,141],5.50082,50.965,{"lat":141,"lon":140},[144],{"name":145,"role":77,"phone":146,"phoneExt":42,"email":147},"Laura Vandenbergh, MD","+32 89 80 83 30","info@zol.be",{"facility":149,"status":83,"city":150,"state":42,"zip":42,"country":85,"countryCode":86,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"UZ Gent","Ghent",{"type":88,"coordinates":152},[153,154],3.71667,51.05,{"lat":154,"lon":153},[157],{"name":158,"role":77,"phone":159,"phoneExt":42,"email":42},"Ben Vanneste, MD PhD","+32 9 332 30 15",{"facility":161,"status":83,"city":162,"state":42,"zip":42,"country":85,"countryCode":86,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Jessa Ziekenhuis","Hasselt",{"type":88,"coordinates":164},[165,166],5.33781,50.93106,{"lat":166,"lon":165},[169],{"name":170,"role":77,"phone":171,"phoneExt":42,"email":172},"Philippe Bulens, MD","011 33 79 79","info@jessazh.be",{"facility":174,"status":83,"city":175,"state":42,"zip":42,"country":85,"countryCode":86,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"AZ Groeninge","Kortrijk",{"type":88,"coordinates":177},[178,179],3.26487,50.82803,{"lat":179,"lon":178},[182],{"name":183,"role":77,"phone":184,"phoneExt":42,"email":185},"Nora Sundahl, MD PhD","+3256 63 39 03","radiotherapie@azgroeninge.be",{"facility":187,"status":83,"city":188,"state":42,"zip":42,"country":85,"countryCode":86,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"CHU HELORA - Hôpital de La Louvière - site Jolimont","La Louvière",{"type":88,"coordinates":190},[191,192],4.18785,50.48657,{"lat":192,"lon":191},[195],{"name":196,"role":77,"phone":197,"phoneExt":42,"email":198},"Samuel Palumbo, MD","064 23 41 88","info@helora.be",{"facility":200,"status":83,"city":201,"state":42,"zip":42,"country":85,"countryCode":86,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"UZ Leuven","Leuven",{"type":88,"coordinates":203},[204,205],4.70093,50.87959,{"lat":205,"lon":204},[208],{"name":209,"role":77,"phone":42,"phoneExt":210,"email":211},"Charlien Berghen, MD, PhD","03216347600","radiotherapie@uzleuven.be",{"facility":213,"status":83,"city":214,"state":42,"zip":42,"country":85,"countryCode":86,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"AZ Sint-Maarten","Mechelen",{"type":88,"coordinates":216},[217,218],4.47762,51.02574,{"lat":218,"lon":217},[221],{"name":222,"role":77,"phone":223,"phoneExt":42,"email":224},"Cédric Draulans, MD","015 89 29 80","azsintmaarten@emmaus.be",{"facility":226,"status":83,"city":227,"state":42,"zip":42,"country":85,"countryCode":86,"cosmosGeoPoint":228,"geoPoint":232,"contacts":233},"CHU UCL Namur - Site Elisabeth","Namur",{"type":88,"coordinates":229},[230,231],4.86746,50.4669,{"lat":231,"lon":230},[234],{"name":235,"role":77,"phone":236,"phoneExt":42,"email":237},"Paul Nguyen, MD","+32 (0)81 72 05 25","sormn.se@chuuclnamur.uclouvain.be",{"facility":239,"status":83,"city":240,"state":42,"zip":42,"country":85,"countryCode":86,"cosmosGeoPoint":241,"geoPoint":245,"contacts":246},"Cliniques universitaires Saint-Luc (UCLouvain)","Woluwe-Saint-Lambert",{"type":88,"coordinates":242},[243,244],4.42912,50.84389,{"lat":244,"lon":243},[247],{"name":248,"role":77,"phone":249,"phoneExt":42,"email":250},"Ad Vandermeulen, MD","+32 2 764 47 52","contact-patient@saintluc.uclouvain.be",{"type":252,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100556325",false,"NCT06523634","Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.","STEREOBED","INCLUSION CRITERIA\n\n1. Localized adenocarcinoma (cN0M0) of the prostate treated primarily with radical prostatectomy with definitive intent.\n2. Either persistent PSA after prostatectomy (PSA ≥ 0.1 ng\u002FmL at least 6 weeks after prostatectomy), or biochemical progression (two consecutive rising PSA amounts with a PSA \\>0.1 ng\u002FmL , or three consecutive PSA rises)\n3. WHO PS 0-1\n4. Age ≥18 years\n5. Ability to understand and willingness to sign a study-specific informed consent prior to study entry\n6. Ability to understand and answer the EPIC-26 form in one of the languages available\n\nEXCLUSION CRITERIA\n\n1. Patients with a pT4 tumor at prostatectomy\n2. Patients with previously pathologically confirmed N1\n3. Patients with macroscopically involved margin at surgery (R2)\n4. Patients with a history of distant metastases\n5. Patients with a recurrence visible on imaging (local, pelvic, or distant). Pelvic nodes with a small diameter \\>1cm and\u002For positive on PSMA without other explanation, are considered as a pelvic recurrence.\n6. Latest PSA \\> 2ng\u002Fml\n7. Patients with a IPSS \\>20\n8. Gleason 10 tumor\n9. Prior history of high-intensity focused ultrasound ablation (HIFU), cryosurgery or brachytherapy of the prostate\n10. Prior pelvic radiotherapy\n11. Prior hormonal therapy started more than 6 weeks before randomization\n12. History of inflammatory bowel disease, ataxia telangiectasia, prior rectal or bladder surgery.\n13. Other active malignancy, except non-melanoma skin cancer, superficial bladder cancer, or malignancies with a documented disease-free survival for a minimum of 3 years before randomization.","MALE","18 Years",{"count":262,"type":263},284,"ESTIMATED","INTERVENTIONAL",[266],"NA","This is a a randomized phase II\u002FIII trial comparing salvage SBRT with standard of care (SOC) regimens for patients with a persistent detectable PSA or biochemical progression during follow-up after radical prostatectomy.",[269],"Prostate Cancer","2026-05-11",{"date":272,"type":273},"2026-05-12","ACTUAL",{"date":275,"type":273},"2024-12-10",{"date":277,"type":263},"2032-02-01",{"name":5,"class":6},13]