[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561042":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":61,"collaborators":12,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":12,"enrollmentInfo":73,"targetDuration":12,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":12,"overallStatus":46,"whyStopped":12,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care therapy","NO_INTERVENTION","The standard of care can consist of surveillance (which means the continuation of the ongoing systemic treatment without any change) or initiation of NEST. The decision which option is considered must be decided at the multidisciplinary urologic oncology meeting (obligatory). MDT is not allowed in this arm. Options for NEST in this trial are abiraterone acetate, enzalutamide, apalutamide, darolutamide, olaparib, talazoparib, niraparib, cabazitaxel and docetaxel, radium-223, luthetium-177-PSMA.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Progression-directed therapy","EXPERIMENTAL","PDT (metastasectomy or SBRT) while continuing current systemic therapy: androgen-deprivation (ADT) alone, or ADT in combination with abiraterone acetate, enzalutamide, apalutamide and patients who had received docetaxel in the past. Patients under current treatment with docetaxel are not allowed, because the hypothesized interaction between docetaxel and radiotherapy concerning toxicity. In case of oligoprogression after PDT, repeated PDT to the new lesions is mandatory.",[18,19],"Radiation: Radiotherapy","Procedure: metastasectomy",[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":12},"RADIATION","Radiotherapy","Progression-directed therapy (stereotactic body radiation therapy)",[14],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":12},"PROCEDURE","metastasectomy","Progression-directed therapy (metastasectomy)",[14],[32],{"name":33,"affiliation":5,"role":34},"Gert De Meerleer, MD, PhD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":12,"email":40},"Kato Rans, MD","CONTACT","003216347600","kato.rans@uzleuven.be",{"name":33,"role":38,"phone":39,"phoneExt":12,"email":42},"gert.demeerleer@uzleuven.be",[44],{"facility":45,"status":46,"city":47,"state":12,"zip":12,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"University Hospitals Leuven","RECRUITING","Leuven","Belgium","BE",{"type":51,"coordinates":52},"Point",[53,54],4.70093,50.87959,{"lat":54,"lon":53},[57,59,60],{"name":37,"role":38,"phone":58,"phoneExt":12,"email":40},"003216340110",{"name":33,"role":38,"phone":39,"phoneExt":12,"email":42},{"name":33,"role":34,"phone":12,"phoneExt":12,"email":12},{"type":62,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100561042","phase-3-metastasis-directed-therapy-in-oligoprogressive-castration-refractory-prostate-cancer-100561042",false,"NCT06585007","Metastasis-directed Therapy in Oligoprogressive Castration-refractory Prostate Cancer","Metastasis-directed Therapy in Oligoprogressive Castration-refractory Prostate Cancer: a Randomized Phase 3 Trial","MEDCARE","Inclusion Criteria:\n\nParticipants eligible for inclusion in this Trial must meet all the following criteria:\n\n* Written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.\n* Acinar adenocarcinoma (inclusive neuro-endocrine dedifferentiation).\n* Oligoprogressive disease on conventional imagine within a maximum of 6 weeks prior to randomisation defined as: a maximum of 3 extracranial progressive lesions (pre-existing lesions, the development of new lesions, or both) in any organ. Nodal (N1) disease should be measured in the short axis. Nodes more than 1.5 cm in the short axis are considered pathologic and measurable. Oligoprogression on bone scan is defined as the occurrence of maximal 3 new and\u002For progressive lesions. In case of not unambiguously, additional imaging such as diagnostic magnetic resonance imaging (MRI) or dedicated CT-scan should be performed. Visceral disease reported separately (lung, liver, adrenal, or CNS) and is considered measurable if an individual lesions is more than 1 cm longest dimension.\n\nIn case of locally persistent\u002Frecurrent disease, a diagnostic MRI of the prostate (bed) and\u002For biopsy of the site is recommended. There are two different mCRPC patient groups who are eligible for inclusion in the trial:\n\n1. Patients with oligoprogressive disease with pADT only as ongoing treatment (Type 1).\n2. Patients with oligoprogressive disease with pADT +\u002F- second line systemic therapy. This is both the combination of pADT + ARTA as ongoing treatment or patients who had received docetaxel in the past (Type 2).\n\n   * Castration-refractory disease, defined as testosterone level \\\u003C 50 ng\u002FdL.\n   * Prior treatment of the primary tumor by radiotherapy or surgery. If the primary tumor has not been treated previously, this treatment is obligatory within the trial.\n   * WHO performance 0-2\n   * Age \\>= 18 years old\n   * Absence of psychological, sociological, or geographical condition potentially hampering compliance with study protocol.\n   * Patients must be presented at the multidisciplinary board meeting and the inclusion in the trial needs approval by this board.\n\nExclusion Criteria:\n\n* Ductal adenocarcinoma and small-cell prostate cancer.\n* Serum testosterone level \\> 50 ng\u002Fml.\n* Presence of poly-progressive disease, defined as more than 3 progressive lesions on conventional imaging or nodal and\u002For metastatic lesions on conventional imaging\n* Active malignancy other than prostate cancer that could potentially interfere with the interpretation of this trial.\n* Previous treatments (RT, surgery) or comorbidities rendering new treatment with SBRT impossible.\n* Spinal bone lesion that is highly symptomatic, neurologically threatening or at risk of fracture.\n* Patients already treated with radionuclides, cabazitaxel or PARP-inhibitors in the past.\n* Patients with progressive disease while receiving docetaxel.\n* Not able to understand the treatment protocol or sign informed consent.","MALE","18 Years",{"count":74,"type":75},246,"ESTIMATED","INTERVENTIONAL",[78],"PHASE3","Evaluation of the impact of metastasis-directed therapy in patients with castration-refractory prostate cancer and a maximum of 5 progressive lesions.",[81,82],"Castration-resistant Prostate Cancer","Oligoprogressive","2024-09-04",{"date":85,"type":86},"2024-09-05","ACTUAL",{"date":88,"type":86},"2023-12-19",{"date":90,"type":75},"2029-01-20",{"name":5,"class":6},1]