[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634512":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":40,"responsibleParty":55,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":80,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Institute of Oncology Ljubljana","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Prophylactic Radiotherapy + Standard of Care","EXPERIMENTAL","Participants receive prophylactic external-beam radiotherapy (25 Gy in 5 fractions) to up to five high-risk asymptomatic or minimally symptomatic bone metastases, in addition to standard of care systemic therapy or observation.",[13,14],"Radiation: Prophylactic External Beam Radiotherapy","Other: Standard of Care",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard of Care","ACTIVE_COMPARATOR","Participants receive standard of care systemic therapy or observation according to tumor type and clinical guidelines, without prophylactic radiotherapy.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Prophylactic External Beam Radiotherapy","External beam radiotherapy delivered to up to five high-risk asymptomatic or minimally symptomatic bone metastases at a total dose of 25 Gy in 5 fractions.",[9],null,{"type":6,"name":16,"description":28,"armGroupLabels":29,"otherNames":26},"Systemic therapy or observation according to tumor type and clinical guidelines.",[9,16],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Eva Ćirić, MD","CONTACT","+38615879623","eciric@onko-i.si",{"name":37,"role":33,"phone":38,"phoneExt":26,"email":39},"Klavdija Korošec","+38631630065","kkorosec@onko-i.si",[41],{"facility":5,"status":26,"city":42,"state":26,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Ljubljana","1000","Slovenia","SI",{"type":47,"coordinates":48},"Point",[49,50],14.50513,46.05108,{"lat":50,"lon":49},[53,54],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},{"name":37,"role":33,"phone":38,"phoneExt":26,"email":39},{"type":56,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100634512","phase-2-prophylactic-radiotherapy-to-prevent-bone-complications-in-patients-with-metastatic-solid-cancers-100634512",false,"NCT07540650","Prophylactic Radiotherapy to Prevent Bone Complications in Patients With Metastatic Solid Cancers","A Randomized Controlled Trial of Early Prophylactic Radiotherapy to Prevent Bone Complications in Patients With Metastatic Solid Cancers","pRevenT","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically confirmed solid malignancy\n* Metastatic disease confirmed by imaging (CT, MRI, or PET-CT)\n* Presence of up to five high-risk bone metastases\n* High-risk bone metastases defined according to protocol criteria\n* Asymptomatic or minimally symptomatic bone metastases (not requiring opioid analgesics)\n* ECOG performance status 0-2\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Prior radiotherapy to the index bone metastases preventing safe treatment planning\n* Symptomatic bone metastases requiring immediate palliative radiotherapy\n* Evidence of spinal cord compression\n* Bone metastases causing significant pain requiring opioid analgesics\n* Oligometastatic disease suitable for radical treatment\n* Leptomeningeal disease\n* ECOG performance status ≥3\n* Life expectancy less than 3 months\n* Any condition that, in the investigator's opinion, would interfere with study participation or assessment","ALL","18 Years",{"count":68,"type":69},90,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","This is a prospective, randomized, single-center clinical trial evaluating whether early prophylactic radiotherapy to high-risk asymptomatic or minimally symptomatic bone metastases reduces the 1-year rate of skeletal-related events (SREs) in patients with metastatic solid cancers. Patients will be randomized in a 1:1 ratio to receive either standard of care systemic therapy or observation, or prophylactic radiotherapy in addition to standard of care. The primary endpoint is the 1-year rate of SREs. Secondary endpoints include adverse events, quality of life, economic burden, pain-free survival, and overall survival.",[75,76],"Bone Metastases","Metastatic Solid Tumor",[78,79],"prophylactic radiotherapy","early radiotherapy","NOT_YET_RECRUITING","2026-04-14",{"date":83,"type":84},"2026-04-20","ACTUAL",{"date":86,"type":69},"2026-04",{"date":88,"type":69},"2029-02",{"name":5,"class":6},1]