[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630129":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":37,"centralContacts":42,"locations":52,"responsibleParty":109,"collaborators":111,"id":115,"slug":27,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":116,"sex":122,"minAge":123,"maxAge":27,"enrollmentInfo":124,"targetDuration":27,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":138,"overallStatus":97,"whyStopped":27,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"CHU de Quebec-Universite Laval","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","ACTIVE_COMPARATOR","Prostate bed 62.5 Gy \u002F 25 Pelvis 45 Gy \u002F 25 (+\u002F-55 Gy\u002F25) ADT",[13,14],"Radiation: Standard Fractionation Post-Operative Salvage Radiotherapy (25 fractions)","Drug: Androgen Deprivation Therapy (ADT)",{"label":16,"type":17,"description":18,"interventionNames":19},"Arm B","EXPERIMENTAL","Prostate bed 52.5 Gy \u002F 20 Pelvis 43 Gy \u002F 20 (+\u002F-52 Gy\u002F20) ADT",[20,14],"Radiation: Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions)",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"RADIATION","Standard Fractionation Post-Operative Salvage Radiotherapy (25 fractions)","Type: Radiation Description: External beam radiotherapy delivered to the prostate bed and pelvis using VMAT\u002FIMRT techniques.\n\nDose and Schedule:\n\nProstate bed: 62.5 Gy in 25 fractions Pelvis: 45 Gy in 25 fractions Duration: Approximately 5 weeks",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions)","Type: Radiation Description: External beam radiotherapy delivered to the prostate bed and pelvis using VMAT\u002FIMRT techniques.\n\nDose and Schedule:\n\nProstate bed: 52.5 Gy in 20 fractions Pelvis: 43 Gy in 20 fractions Duration: Approximately 4 weeks",[16],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"DRUG","Androgen Deprivation Therapy (ADT)","Type: Drug Description: Hormonal therapy with a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin) ± short-term anti-androgen.\n\nDuration: 6 to 24 months, at physician's discretion. Additional Notes: Patients with pelvic nodal disease may receive abiraterone and prednisone for 24 months as per STAMPEDE protocol.",[9,16],[38],{"name":39,"affiliation":40,"role":41},"Eric Vigneault, MD, MSc","CHU de Québec-Université Laval","PRINCIPAL_INVESTIGATOR",[43,47],{"name":39,"role":44,"phone":45,"phoneExt":27,"email":46},"CONTACT","418 691-5264","eric.vigneault.med@ssss.gouv.qc.ca",{"name":48,"role":44,"phone":49,"phoneExt":50,"email":51},"Damien Carignan, PhD","418 525-4444","67854","damien.carignan@crchudequebec.ulaval.ca",[53,71,85,96],{"facility":54,"status":55,"city":56,"state":57,"zip":27,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Gatineau Hospital","NOT_YET_RECRUITING","Gatineau","Quebec","Canada","CA",{"type":61,"coordinates":62},"Point",[63,64],-75.70164,45.47723,{"lat":64,"lon":63},[67],{"name":68,"role":44,"phone":69,"phoneExt":27,"email":70},"Steven Tisseverasinghe, MD","819-966-6100","steven.tisseverasinghe.med@ssss.gouv.qc.ca",{"facility":72,"status":55,"city":73,"state":57,"zip":74,"country":58,"countryCode":59,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Hôpital Général Juif","Montreal","H3T 1E2",{"type":61,"coordinates":76},[77,78],-73.58781,45.50884,{"lat":78,"lon":77},[81],{"name":82,"role":44,"phone":83,"phoneExt":27,"email":84},"Tamim Niazi, MD","514-340-8288","tniazi@mcgill.ca",{"facility":86,"status":55,"city":73,"state":57,"zip":87,"country":58,"countryCode":59,"cosmosGeoPoint":88,"geoPoint":90,"contacts":91},"McGill University Health Centre","H4A 3J1",{"type":61,"coordinates":89},[77,78],{"lat":78,"lon":77},[92],{"name":93,"role":44,"phone":94,"phoneExt":27,"email":95},"James MG Tsui, MS, PhD","514-934-4400","james.tsui@mcgill.ca",{"facility":40,"status":97,"city":98,"state":57,"zip":99,"country":58,"countryCode":59,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"RECRUITING","Québec","G1G 5X1",{"type":61,"coordinates":101},[102,103],-71.21454,46.81228,{"lat":103,"lon":102},[106,107],{"name":39,"role":44,"phone":45,"phoneExt":27,"email":46},{"name":48,"role":44,"phone":49,"phoneExt":108,"email":51},"67853",{"type":110,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[112],{"name":113,"class":114},"TerSera Therapeutics LLC","INDUSTRY","100630129",false,"NCT07483658","Non-inferiority Study Comparing Salvage Pelvic Radiotherapy in 25 Fractions (62.5 Gy\u002F25) Versus 20 Fractions (52.5 Gy\u002F20) for Recurrent Prostate Cancer After Surgery.","Non-Inferiority Study Comparing Hypofractionated Post-Operative Salvage Radiotherapy Regimens: 45\u002F62.5 Gy in 25 Fractions vs. 43\u002F52.5 Gy in 20 Fractions for Grade 2+ GU or GI Toxicity (HYP-OP-RT)","HYP-OP-RT","Inclusion Criteria:\n\n* Histologically confirmed prostate adenocarcinoma.\n* Prior radical prostatectomy with detectable PSA (≥0.2 ng\u002FmL).\n* No evidence of distant metastasis (confirmed via bone scan and CT\u002FMRI or TEP-PSMA if PSA is above 0.5 ng \u002Fml).\n* Patient with Nodal recurrence within the pelvis are eligible\n* ECOG performance status 0-2.\n* Age ≥ 18 years.\n* Adequate baseline renal, hepatic, and hematologic function.\n\nExclusion Criteria:\n\n* Prior pelvic radiotherapy.\n* Macroscopic local relapse on imaging\n* Presence of metastatic disease.\n* Active inflammatory bowel disease or other GI conditions predisposing to radiation toxicity.\n* Uncontrolled comorbidities affecting study participation.\n* Prior systemic therapy for recurrent prostate cancer (except ADT within 6 months).","MALE","18 Years",{"count":125,"type":126},434,"ESTIMATED","INTERVENTIONAL",[129],"NA","Study Overview This research compares two types of post-operative salvage radiotherapy (SRT) for men with prostate cancer who have had surgery but show signs of recurrence (detectable PSA). The goal is to see if a shorter treatment schedule is as safe and effective as the standard schedule.\n\nWhy is this study important? After prostate surgery, cancer can return in up to 70-80% of high-risk patients. Radiotherapy helps control this, but the best way to deliver it-especially the number of sessions and whether to treat the pelvic area-is still being studied. Shorter treatments could mean less time in therapy and better quality of life, if such treatments are proven safe.\n\nWhat is being compared?\n\nStandard treatment (Arm A):\n\n25 sessions (about 5 weeks) Prostate bed: 62.5 Gy Pelvis: 45 Gy\n\nShorter treatment (Arm B):\n\n20 sessions (about 4 weeks) Prostate bed: 52.5 Gy Pelvis: 43 Gy\n\nBoth groups may also receive hormone therapy (ADT) for 6-24 months.\n\nMain Goal To check if the shorter treatment causes no more side effects (urinary or bowel problems) than the standard treatment, while keeping cancer control similar.\n\nOther Things to be Measured\n\nCancer control (PSA levels, spread of disease) Survival Quality of life (urinary, bowel, sexual health questionnaires)\n\nWho can join?\n\nMen who:\n\nHad prostate surgery Have a detectable PSA (≥0.2 ng\u002FmL) No distant metastasis Are in good general health (ECOG 0-2)\n\nHow long will the study last?\n\nAbout 12 years total:\n\n2 years to enroll patients 10 years of follow-up",[132,133,134,135,136,137],"Reccurent\u002FMetastatic Solid Tumor Disease","Prostate Cancer (Post Prostatectomy)","Prostate Cancer","Prostatic Neoplasms","Neoplasm Recurrence, Local","Biochemical Recurrence of Malignant Neoplasm of Prostate",[139,140,141,142,143,144,145,146,147,148,149,150],"Radiotherapy, Adjuvant","Radiotherapy, Intensity-Modulated","Radiotherapy, High-Dose Hypofractionated","Pelvic Radiotherapy","Androgen Deprivation Therapy","Randomized Controlled Trials","Noninferiority Trials","Quality of Life","Treatment Outcome","Gastrointestinal Diseases \u002F chemically induced","Urinary Tract Diseases \u002F chemically induced","Radiation Injuries","2026-06-29",{"date":153,"type":154},"2026-07-01","ACTUAL",{"date":156,"type":154},"2026-05-13",{"date":158,"type":126},"2036-02",{"name":5,"class":6},4]