[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595888":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":56,"collaborators":20,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":20,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":20,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University Medical Center Groningen","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MDRT to oligoprogression","EXPERIMENTAL","Patients included in the study with a post prostatectomy local recurrence on the PSMA PET with up to 3 oligometastases will be treated preferably with SBRT to all oligometastatic lesions and to the local recurrence in prostate bed",[13],"Radiation: Metastasis directed radiotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","Metastasis directed radiotherapy","According to guidelines, in the case of oligoprogression next line systemic treatment is recommended. This study investigates the potential delay of NEST and rPFS by MDRT.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Shafak Aluwini","CONTACT","+31625649975","s.al-uwini@umcg.nl",[28,42],{"facility":29,"status":30,"city":31,"state":20,"zip":20,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"UMC Groningen","RECRUITING","Groningen","Netherlands","NL",{"type":35,"coordinates":36},"Point",[37,38],6.56667,53.21917,{"lat":38,"lon":37},[41],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"facility":43,"status":44,"city":45,"state":20,"zip":20,"country":32,"countryCode":33,"cosmosGeoPoint":46,"geoPoint":50,"contacts":51},"Radboud Umc","NOT_YET_RECRUITING","Nijmegen",{"type":35,"coordinates":47},[48,49],5.85278,51.8425,{"lat":49,"lon":48},[52],{"name":53,"role":24,"phone":54,"phoneExt":20,"email":55},"Robert Jan Smeenk","+31 (024) 361 45 05","RobertJan.Smeenk@radboudumc.nl",{"type":57,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100595888","phase-2-the-impact-of-metastatic-directed-radiotherapy-mdrt-on-oligoprogressive-castration-resistant-prostate-cancer-crpc-100595888",false,"NCT07038304","The Impact of Metastatic Directed Radiotherapy (MDRT) on Oligoprogressive Castration Resistant Prostate Cancer (CRPC)","Oligometastatic Directed Radiotherapy for Patients With Castration Resistant Prostate Cancer","OLYMPIAN","Inclusion Criteria:\n\n* Adenocarcinoma of the prostate.\n* mCRPC setting, with testosterone level \\\u003C 50 ng\u002Fdl or 1.7 nmol\u002Fl.\n* Oligoprogressive disease diagnosed on PSMAscan; defined as the progression of pre-existing metastatic disease, and\u002For the appearance of new metastases and\u002For the appearance of a local relapse with a maximum of 3 lesions in total.\n* Patients currently treated with ADT, whether combined with another systemic treatment such as ARTA, chemotherapy.\n* For patients treated with chemotherapy, the course should be completed or stopped before start MORT - In case of treatment with ARTA, a minimal of 3 months response (PSA or clinical response).\n* WHO performance status 0-2.\n* Age \\> = 18 years old.\n* Patiënt should be presented at the multidisciplinary tumor board of the local hospital in which the therapy will be given.\n* Before patiënt registration, written informed consent must be given according to ICH\u002FGCO and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* Serum testosterone level \\> 50 ng\u002Fml or \\> 1.7 nmol\u002Fl.\n* Presence of more than 3 progressive\u002Fnew metastatic lesions and\u002For local recurrence (which counts for 1 lesion).\n* Active malignancy other than prostate cancer that can potentially interfere with the interpretation of the trial, except non-melanoma skin cancer or non-invasive urothelial cell carcinoma.\n* Local recurrence in the prostate after previous radiotherapy\n* Previous treatments (RT, surgery) or comorbidities making new treatment with MDRT impossible.\n* Disorder precluding understanding of trial Information or informed consent or signing informed consent.\n* Evidence of PSMA-negative disease.","MALE","18 Years",{"count":69,"type":70},35,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","In patients with metastatic prostate cancer (PCa) who receive androgen deprivation therapy (ADT), the sensitivity to castration will eventually disappear due to the selection of castration-refractory clones. This will lead to the stage of metastatic castration-refractory prostate can-cer (mCRPC), which is incurable and results in a median overall survival of 2-3 years.\n\nTreatment options for patients with mCRPC include several systemic agents, such as andro-gen receptor-targeted agents (ARTA), chemotherapy (docetaxel, cabazitaxel) and bone-targeting agents (radium- 223). Clinical progression and, to a lesser extent, biochemical pro-gression traditionally imply a switch to the next line systemic treatment (NEST). Within patients with mCRPC, there is a subgroup showing oligo-progression, defined as the progression of up to 3 lesions, including both metastatic and\u002For local relapse. Oligoprogression reflects a heterogeneous treatment response, which, in turn, reflects the heterogeneity of the clonogenic cells that give rise to mCRPC. Retrospective studies suggest that metastasis-directed radiotherapy (MDRT) to these oligoprogressive lesions delayed the need for NEST. Recently, promising results were published on the use of MDRT in the oligopro-gressive mCRPC (omCRPC) setting, with a NEST-free survival (NEST-FS) of 21 months in well selected patients. Currently, in The Netherlands, patients with omCRPC are frequently referred and treated with MDRT, but a clear treatment protocol and inclusion\u002Fselection criteria are missing. Moreover, the exact benefit of MDRT in patients with omCRPC remains unclear, as prospective evi-dence for MDRT in omCRPC is lacking.",[76,77,78,79],"Prostate Cancer (Adenocarcinoma)","OligoProgressive Metastatic Disease","Castration Resistant Metastatic Prostate Cancer","Radiotherapy","2025-06-17",{"date":82,"type":83},"2025-06-26","ACTUAL",{"date":85,"type":83},"2025-01-03",{"date":87,"type":70},"2029-01-03",{"name":5,"class":6},2]