[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Robert Förster\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100656853","phase-3-risk-adapted-stereotactic-radiotherapy-vs-standard-of-care-radiotherapy-in-patients-with-prostate-cancer-in-the-adjuvant-or-salvage-setting-with-or-without-lymph-node-irradiation-riddleln---a-phase-iii-trial-100656853",false,"NCT07830511","RIsk aDapted Stereotactic Radiotherapy vs. standarD of Care Radiotherapy in Patients With Prostate Cancer in the Adjuvant or saLvage sEtting With or Without Lymph Node Irradiation (RIDDLELN) - A Phase III Trial","RIDDLELN","Inclusion Criteria:\n\n* Confirmed prostate cancer treated with radical prostatectomy (≥ 6 months since radical prostatectomy)\n* Indication for adjuvant or salvage radiotherapy (e.g. persisting or rising PSA, macroscopic recurrence, R1 resection, pT3b) at the discretion of the treating physician\n* Androgen deprivation therapy allowed at the discretion of the treating physician\n* WHO performance status 0-1\n* Age ≥ 18 years\n* Indication for treatment of the locoregional lymphatic drainage at the discretion of the treating physician allowed (not mandatory)\n* Personally signed and dated written informed consent\n\nExclusion Criteria:\n\n* Inability to follow the procedures of the study (e.g. due to language problems, psychological disorders, dementia)\n* Comorbidities which predispose to significant radiotherapy toxicities (e.g. inflammatory bowel disease), at the discretion of the treating physician\n* Prior radiotherapy to the intended treatment site\n* Presence of distant metastases (M1a is not an exclusion criterion)","MALE","18 Years",{"count":19,"type":20},206,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The goal of this clinical trial is to determine whether stereotactic body radiotherapy (SBRT) delivered in five fractions is non-inferior to standard-of-care mildly hypofractionated radiotherapy in terms of patient-reported quality of life in adults with prostate cancer who require adjuvant or salvage radiotherapy after radical prostatectomy. The trial includes patients with or without a macroscopic recurrence in the prostate bed and allows irradiation of the regional lymphatic drainage when clinically indicated.\n\nThe main questions it aims to answer are:\n\n* Is SBRT non-inferior to standard-of-care radiotherapy regarding urinary (GU) quality of life, measured by the change in the EPIC-26 GU domain score from baseline to 24 months after radiotherapy?\n* Is SBRT non-inferior to standard-of-care radiotherapy regarding bowel (GI) quality of life, measured by the change in the EPIC-26 GI domain score from baseline to 24 months after radiotherapy?\n\nResearchers will compare SBRT delivered as 6 Gy × 5 fractions to the prostate bed with standard-of-care radiotherapy delivered as 2.625 Gy × 20 fractions (total dose 52.5 Gy) to determine whether the substantially shorter SBRT treatment provides non-inferior patient-reported urinary and bowel outcomes. When clinically indicated, treatment of the lymphatic drainage and a simultaneous integrated boost to macroscopic recurrence or involved lymph nodes may also be delivered.\n\nParticipants will:\n\n* Be randomly assigned in a 1:1 ratio to receive either five-fraction SBRT or 20-fraction standard-of-care radiotherapy.\n* Receive radiotherapy to the prostate bed, with additional irradiation of the regional lymphatic drainage and\u002For a boost to macroscopic disease or involved lymph nodes when clinically indicated.\n* Complete questionnaires assessing quality of life, urinary symptoms, and sexual function, including EPIC-26, IPSS, and IIEF-5.\n* Undergo clinical assessments, PSA measurements, assessment of treatment-related adverse events, and radiological imaging when clinically indicated.\n* Attend follow-up assessments at 3, 6, 12, 18, and 24 months after radiotherapy and then annually for up to 5 years.\n\nA total of 206 participants are planned for the trial. In addition to the primary quality-of-life outcomes, researchers will assess acute and late toxicity, biochemical recurrence-free survival, progression-free survival, time to further anti-cancer therapy, prostate cancer-specific survival, and overall survival.",[26,27,28],"Prostate Cancer (Post Prostatectomy)","Prostate Cancer","SBRT",[28,27],"NOT_YET_RECRUITING","2026-09-15",{"date":33,"type":34},"2026-09-21","ACTUAL",{"date":36,"type":20},"2026-09-01",{"date":38,"type":20},"2034-09-01",{"name":40,"class":41},"Robert Förster","OTHER",""]