[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531329":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":20,"centralContacts":26,"locations":35,"responsibleParty":52,"collaborators":20,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":20,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":20,"overallStatus":75,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Changhai Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"hormone and RT","EXPERIMENTAL","Patients with de novo oligo-metastatic prostate cancer will receive a two-year course of androgen deprivation therapy (ADT) in combination with abiraterone, along with synchronous metastasis-directed radiation and prostate radiotherapy.",[13,14],"Radiation: hormone and RT","Drug: ADT combined with abiraterone",[16,21],{"type":17,"name":9,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","The patients will receive a two-year course of androgen deprivation therapy (ADT) in combination with abiraterone, along with synchronous metastasis-directed radiation and prostate radiotherapy(RT).",[9],null,{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":20},"DRUG","ADT combined with abiraterone","The patients will receive a two-year course of ADT combined with abiraterone.",[9],[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Zhang Huojun, PHD","CONTACT","021-31162222","huojunzh@163.com",{"name":33,"role":29,"phone":30,"phoneExt":20,"email":34},"Bichun Xu, MD","bchunxu@163.com",[36],{"facility":37,"status":20,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Shanghai Changhai Hospital","Shanghai","Shanghai Municipality","200433","China","CN",{"type":44,"coordinates":45},"Point",[46,47],121.45806,31.22222,{"lat":47,"lon":46},[50],{"name":51,"role":29,"phone":30,"phoneExt":20,"email":31},"Zhang Huojun",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Zhang Huo Jun","Professor","100531329","radiotherapy-for-prostate-and-oligo-metastatic-lesions-in-patients-with-low-burden-oligo-metastatic-prostate-cancer-100531329",false,"NCT06198387","Radiotherapy for Prostate and Oligo-metastatic Lesions in Patients With Low-burden Oligo-metastatic Prostate Cancer","Efficacy and Safety of Radiotherapy for Prostate and Oligo-metastatic Lesions in Patients With Low-burden Oligo-metastatic Prostate Cancer: An Open, Exploratory Pilot Clinical Trial","Inclusion Criteria:\n\n* Aged 18 years or over at the time of registration\n* Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;\n* Histologically confirmed prostate adenocarcinoma via prostate biopsy;\n* Assessment conducted via single-photon emission computed tomography (SPECT), magnetic resonance imaging (MRI), and Ga-68 prostate-specific membrane antigen (PSMA) positron emission tomography\u002Fcomputed tomography(PET\u002FCT), revealing oligo-metastasis (involving \\\u003C 4 metastatic lesions in non-pelvic lymph nodes and bones) with or without pelvic lymph node involvement;\n* Expected survival duration \\>2 years.\n* The willingness of patients to voluntarily accept the experimental research protocol after being informed of existing treatment options.\n\nExclusion Criteria:\n\n* Any previous or ongoing treatment for prostate cancer, including radiotherapy, chemotherapy, focal treatment, etc.\n* Pathology indicating small-cell or neuroendocrine tumor components;\n* Patients with visceral metastases, or ≥4 metastases;\n* Patients with concurrent malignancies or those in an acute infection period or severe infection state; patients positive for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), and\u002For syphilis (Treponema pallidum)\n* Severe or active systemic comorbidities that, in the investigator's judgment, might interfere with the treatment, evaluation, and compliance of this trial, including severe conditions affecting respiratory, circulatory, nervous, mental, digestive, endocrine, immune, urological, and other systems;\n* Individuals with contraindications related to radiation therapy may present heightened risks of treatment-related complications.\n* Patients participating in other clinical trials;\n* Patients unsuitable for participation in this clinical trial as per the judgement of the investigator.","MALE","18 Years","75 Years",{"count":67,"type":68},30,"ESTIMATED","INTERVENTIONAL",[71],"NA","The existing large prospective study demonstrates the benefits of primary radiotherapy in patients with low-volume oligo-metastatic prostate cancer (OMPC), and there is also more evidence of the benefits of local metastasis-directed therapy (MDT) for metastatic lesions. But there is no results from prospective study to demonstrate the efficacy of radiotherapy for prostate and oligo-metastases. Therefore, the aim of the protocol is to illustrate the efficacy of radiotherapy for prostate and oligo-metastatic lesions in patients with de novo OMPC.",[74],"Oligo-metastatic Prostate Carcinoma","NOT_YET_RECRUITING","2024-01-08",{"date":78,"type":79},"2024-01-10","ACTUAL",{"date":81,"type":68},"2024-01-01",{"date":83,"type":68},"2028-09-01",{"name":5,"class":6},1]