[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566803":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":21,"centralContacts":26,"locations":33,"responsibleParty":107,"collaborators":109,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":31,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":121,"maxAge":31,"enrollmentInfo":122,"targetDuration":31,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":36,"whyStopped":31,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"The Netherlands Cancer Institute","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"mCRPC patients with bone-only disease according to 68Ga-PSMA-PET\u002FCT","a prospective clinical study in which patients with mCRPC and bone-only disease according to ceCT and bone scan will receive standard-of-care treatment with Radium-223. In addition to standard-of-care systemic treatment, each patient will undergo an additional 68Ga-PSMA-PET\u002FCT scan at baseline and will be followed throughout the treatment with online patient reported outcome measure (PROM) questionnaires (Kaiku application) and blood sampling for circulating tumor DNA (ctDNA) analysis.",[12],"Other: 68Ga-PSMA-PET\u002FCT scan",[14],{"type":6,"name":15,"description":16,"armGroupLabels":17,"otherNames":18},"68Ga-PSMA-PET\u002FCT scan","68Ga-PSMA-PET\u002FCT scan at baseline and will be followed throughout the treatment with online patient reported outcome measure (PROM) questionnaires (Kaiku application) and blood sampling for circulating tumor DNA (ctDNA) analysis. At clinical progression, each patient will undergo a second 68Ga-PSMA-PET\u002FCT to determine the location of disease progression and assess the value of 68Ga-PSMA-PET\u002FCT imaging as a response measure",[9],[19,20],"Online patient reported outcome measure (PROM) questionnaires","Blood sampling",[22],{"name":23,"affiliation":24,"role":25},"J.C. van der Mijn","NKI-AvL","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"J.C. van der Mijn, Dr.","CONTACT","+31205129111",null,"k.vd.mijn@nki.nl",[34,53,68,82,96],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"NKI-AVL","RECRUITING","Amsterdam","North Holland","1066CX","Netherlands","NL",{"type":43,"coordinates":44},"Point",[45,46],4.88969,52.37403,{"lat":46,"lon":45},[49,51],{"name":50,"role":29,"phone":30,"phoneExt":31,"email":32},"J.C. van der Mijn, MD, PhD",{"name":52,"role":25,"phone":31,"phoneExt":31,"email":31},"Koen van der Mijn, MD, PhD",{"facility":54,"status":36,"city":55,"state":56,"zip":57,"country":40,"countryCode":41,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Meander Medisch Centrum","Amersfoort","Utrecht","3813TZ",{"type":43,"coordinates":59},[60,61],5.3875,52.155,{"lat":61,"lon":60},[64],{"name":65,"role":29,"phone":66,"phoneExt":31,"email":67},"Joyce Dodewaard, MD, PhD","+31 (0)33-8501189","jm.van.dodewaard@meandermc.nl",{"facility":69,"status":36,"city":70,"state":56,"zip":71,"country":40,"countryCode":41,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Sint Antonius ziekenhuis","Nieuwegein","3430EM",{"type":43,"coordinates":73},[74,75],5.08056,52.02917,{"lat":75,"lon":74},[78],{"name":79,"role":29,"phone":80,"phoneExt":31,"email":81},"Jules Lavalaye, MD, PhD","+31 883207500","j.lavalaye@antoniusziekenhuis.nl",{"facility":83,"status":84,"city":56,"state":31,"zip":85,"country":40,"countryCode":41,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Diakonessenhuis","NOT_YET_RECRUITING","3582KE",{"type":43,"coordinates":87},[88,89],5.12222,52.09083,{"lat":89,"lon":88},[92],{"name":93,"role":29,"phone":94,"phoneExt":31,"email":95},"Tanja Oostergo, MD, MSc","+31 88 250 9810","toostergo@diakhuis.nl",{"facility":97,"status":36,"city":56,"state":31,"zip":98,"country":40,"countryCode":41,"cosmosGeoPoint":99,"geoPoint":101,"contacts":102},"UMC","3584CX",{"type":43,"coordinates":100},[88,89],{"lat":89,"lon":88},[103],{"name":104,"role":29,"phone":105,"phoneExt":31,"email":106},"Marnix Lam, MD, PhD","+31887555555","m.lam@umcutrecht.nl",{"type":108,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[110],{"name":111,"class":112},"Bayer","INDUSTRY","100566803","the-radium-select-study-100566803",false,"NCT06659926","The Radium-select Study","68Ga-PSMA-PET\u002FCT and Genomic Alterations for Future Selection of Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) for Radium-223 Treatment.","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate.\n* Progressive disease after previous treatment defined as a rise in serum (Prostate Specific Antigen) PSA (PCWG3 criteria(22), see appendix 1) and\u002For progression on conventional imaging (PCWG3).\n* A positive bone scan (osteoblastic bone metastases), with at least two metastases.\n* Hemoglobin concentration \\>10 g\u002Fdl (6.2 mmol\u002Fl) and thrombocytes \\>100 109\u002FI at baseline.\n* Each patient will need to (continue to) receive adequate bone protective agents (e.g. bisphosphonates) and androgen deprivation therapy (ADT) according to current clinical guidelines.\n\nExclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance score \\>2\n* Life expectancy \\\u003C 6 months.\n* Detected extra-skeletal metastases or lymph node metastases (\\>3 cm short axis) as identified by conventional imaging (ceCT thorax\u002Fabdomen)","MALE","18 Years",{"count":123,"type":124},60,"ESTIMATED","INTERVENTIONAL",[127],"NA","Radium-223 is an established radionuclide therapy for patients with metastatic castration resistant prostate cancer (mCRPC) and symptomatic bone metastasis. Patients are eligible for this treatment when they have mCRPC and bone metastases; limited extraskeletal lesions (local prostate, lymph nodes \\\u003C3 cm) on conventional contrast enhanced CT (ceCT) were allowed in the registration trial(1). Previous research revealed that extraskeletal disease on ceCT and bone scans correlates with a poor response. Meanwhile, 68Ga-PSMA-PET\u002FCT emerged as more sensitive imaging strategy that increases the detection of extraskeletal prostate cancer metastases. It is unclear whether these extraskeletal lesions harbour any predictive value in the treatment of mCRPC patients with Radium-223.",[130,131],"mCRPC","Male Urogenital Diseases",[130,133,134,135],"68Ga-PSMA-PET\u002FCT","Radium-223","Bone only-disease","2025-07-04",{"date":138,"type":139},"2025-07-08","ACTUAL",{"date":141,"type":139},"2025-02-24",{"date":143,"type":124},"2029-07-01",{"name":5,"class":6},5]