[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647042":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":43,"centralContacts":47,"locations":56,"responsibleParty":74,"collaborators":10,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":10,"enrollmentInfo":87,"targetDuration":90,"studyType":91,"phases":10,"briefSummary":92,"conditions":93,"keywords":98,"overallStatus":59,"whyStopped":10,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Affidea Nu-med Center of Oncological DIagnostics and Therapy","OTHER",[8,17,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Historical Retrospective Cohort",null,"Eligible patients treated before registry activation. Baseline disease characteristics, imaging, treatment details, follow-up, radiographic progression, adverse events, subsequent therapy, and survival data are abstracted retrospectively from available medical records.",[13,14,15,16],"Radiation: Definitive Prostate-Directed Radiotherapy","Radiation: Metastasis-Directed Stereotactic Body Radiotherapy","Radiation: Pelvic Lymph Node Irradiation","Radiation: Prostate Brachytherapy",{"label":18,"type":10,"description":19,"interventionNames":20},"Ambispective Follow-Up Cohort","Eligible patients treated before registry activation who remain under follow-up. Baseline and treatment data are collected retrospectively, while follow-up updates after registry activation, including imaging, progression, subsequent therapy, adverse events, and survival, are collected prospectively where permitted.",[13,14,15,16],{"label":22,"type":10,"description":23,"interventionNames":24},"Prospective Enrollment Cohort","Newly eligible patients identified from registry activation onward and entered prospectively before, during, or shortly after routine clinical decision-making for definitive prostate-directed radiotherapy and metastasis-directed therapy. Treatment is not assigned by the registry.",[13,14,15,16],[26,31,35,39],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"RADIATION","Definitive Prostate-Directed Radiotherapy","Definitive radiotherapy to the prostate delivered as part of routine clinical practice. Techniques may include external-beam radiotherapy, moderately hypofractionated radiotherapy, ultra-hypofractionated prostate radiotherapy, external-beam radiotherapy with brachytherapy boost, or definitive prostate brachytherapy monotherapy in selected patients.",[18,9,22],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"Metastasis-Directed Stereotactic Body Radiotherapy","Stereotactic body radiotherapy delivered with ablative intent to all identified extraregional metastatic lesions at baseline. Dose, fractionation, target site, number of treated lesions, and treatment sequence are determined by routine institutional practice and recorded in the registry.",[18,9,22],{"type":27,"name":36,"description":37,"armGroupLabels":38,"otherNames":10},"Pelvic Lymph Node Irradiation","Elective or definitive pelvic lymph node irradiation, with or without dose escalation to involved pelvic lymph nodes, delivered according to institutional standards. This treatment is permitted but not mandatory and is recorded as a treatment-related variable.",[18,9,22],{"type":27,"name":40,"description":41,"armGroupLabels":42,"otherNames":10},"Prostate Brachytherapy","High-dose-rate or low-dose-rate prostate brachytherapy delivered either as a boost after external-beam radiotherapy or as definitive brachytherapy monotherapy in selected patients, according to institutional practice.",[18,9,22],[44],{"name":45,"affiliation":5,"role":46},"Mateusz Bilski, MD, PhD","PRINCIPAL_INVESTIGATOR",[48,53],{"name":45,"role":49,"phone":50,"phoneExt":51,"email":52},"CONTACT","81 536 04 50","+48","mateusz.bilski@affidea.com",{"name":54,"role":49,"phone":50,"phoneExt":51,"email":55},"Paulina Kleban","paulina.kleban@affidea.com",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Affidea Nu-med Center of Oncological Diagnostics and Therapy","RECRUITING","Zamość","Lublin Voivodeship","22-400","Poland","PL",{"type":66,"coordinates":67},"Point",[68,69],23.25196,50.72314,{"lat":69,"lon":68},[72,73],{"name":45,"role":49,"phone":50,"phoneExt":51,"email":52},{"name":54,"role":49,"phone":50,"phoneExt":51,"email":55},{"type":46,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Mateusz Bilski","Principal Investigator, Medical Director and Head of Radiotherapy Department","100647042","prostate-radiotherapy-and-metastasis-directed-therapy-in-synchronous-oligometastatic-prostate-cancer-100647042",false,"NCT07686016","Prostate Radiotherapy and Metastasis-Directed Therapy in Synchronous Oligometastatic Prostate Cancer","Outcomes and Patterns of Failure After Definitive Prostate-Directed Radiotherapy and Metastasis-Directed Therapy in Patients With Synchronous De Novo Prostate Cancer and Up to 10 Metastases: An Ambispective Multicenter Real-World Evidence Registry","SynSABR-PC","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate.\n* Male sex.\n* Age 18 years or older.\n* Synchronous de novo metastatic prostate cancer diagnosed at initial presentation or within 6 months of primary prostate cancer diagnosis.\n* Up to 10 extraregional metastatic lesions on staging imaging used for clinical decision-making.\n* Treatment with definitive prostate-directed radiotherapy, including external-beam radiotherapy alone, external-beam radiotherapy with brachytherapy boost, or definitive prostate brachytherapy monotherapy in selected patients.\n* Treatment with SBRT or another ablative metastasis-directed radiotherapy approach to all identified extraregional metastatic lesions.\n* Availability of sufficient clinical, imaging, radiotherapy, systemic therapy, follow-up, adverse event, and survival data for outcome assessment.\n* For prospectively enrolled patients, ability to provide informed consent where required by local ethics and regulatory procedures.\n\nExclusion Criteria:\n\n* More than 10 extraregional metastatic lesions at baseline staging.\n* Incomplete metastasis-directed therapy, defined as treatment of selected metastatic lesions only while leaving other known baseline extraregional metastatic sites untreated.\n* Prostate-directed radiotherapy delivered with palliative rather than definitive intent.\n* Missing key dates preventing outcome determination, including prostate-directed radiotherapy, brachytherapy, metastasis-directed SBRT dates, or follow-up information.\n* Prior definitive treatment of prostate cancer before diagnosis of synchronous metastatic disease.\n* Histology other than adenocarcinoma of the prostate.","MALE","18 Years",{"count":88,"type":89},700,"ESTIMATED","3 Years","OBSERVATIONAL","This is an ambispective, multicenter, observational real-world registry of patients with synchronous de novo oligometastatic prostate cancer, defined as prostate cancer with up to 10 extraregional metastatic lesions diagnosed at initial presentation or within 6 months of the primary diagnosis.\n\nThe study will evaluate outcomes after comprehensive local and metastasis-directed treatment. Eligible patients receive definitive prostate-directed radiotherapy, which may include external-beam radiotherapy, external-beam radiotherapy with brachytherapy boost, or definitive prostate brachytherapy monotherapy in selected patients, together with stereotactic body radiotherapy to all identified extraregional metastatic lesions. Systemic therapy is given according to routine clinical practice and local multidisciplinary decisions.\n\nThe registry is non-interventional. Participants are not assigned to treatment by the study protocol, and no experimental treatment, randomization, or protocol-mandated imaging schedule is used. The study collects de-identified data from routine medical records, including baseline disease characteristics, imaging, radiotherapy details, systemic therapy, radiographic progression, patterns of failure, subsequent treatments, adverse events, and survival.\n\nThe study includes historical retrospective data, prospective follow-up of previously treated eligible patients, and prospective enrollment of newly eligible patients from the registry activation date. The main goal is to describe where and when prostate cancer progresses after comprehensive treatment of the prostate and all visible metastatic lesions, and to identify clinical and treatment-related factors associated with disease control and adverse events.",[94,95,96,97],"Prostate Cancer","Metastatic Prostate Cancer","Oligometastatic Prostate Cancer","Synchronous Oligometastatic Prostate Cancer",[99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114],"synchronous de novo oligometastatic prostate cancer","metastasis-directed therapy","stereotactic body radiotherapy","definitive prostate radiotherapy","prostate brachytherapy","SBRT","brachytherapy boost","PSMA PET","up to 10 metastases","patterns of failure","radiographic progression","polymetastatic progression","real-world evidence","ambispective registry","prospective registry","adverse events","2026-07-02",{"date":117,"type":118},"2026-07-06","ACTUAL",{"date":120,"type":118},"2026-06-26",{"date":122,"type":89},"2029-12-30",{"name":5,"class":6},1]