[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493616":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":41,"responsibleParty":116,"collaborators":26,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":26,"eligibilityCriteria":126,"healthyVolunteers":122,"sex":127,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":26,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":26,"overallStatus":139,"whyStopped":26,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Changhai Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"A (hormone)","ACTIVE_COMPARATOR","The patients in arm A with oligometastatic PCa will receive long-term ADT combined with abiraterone.",[13],"Drug: ADT combined with abiraterone",{"label":15,"type":16,"description":17,"interventionNames":18},"B (neoadjuvant hormone and RT)","EXPERIMENTAL","The patients in arm B with oligometastatic PCa will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued.",[19],"Radiation: neoadjuvant hormone and RT",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","ADT combined with abiraterone","The patients will receive long-term ADT combined with abiraterone.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"RADIATION","neoadjuvant hormone and RT","The patients will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued.",[15],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Huojun Zhang, PhD","CONTACT","021-31162222","huojunzh@163.com",{"name":39,"role":35,"phone":36,"phoneExt":26,"email":40},"Xianzhi Zhao, MD","zhxzh0007@163.com",[42,58,70,82,94,108],{"facility":43,"status":26,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"the First Affiliated Hospital of Guangzhou Medical University","Guangzhou","Guangdong","510120","China","CN",{"type":50,"coordinates":51},"Point",[52,53],113.25,23.11667,{"lat":53,"lon":52},[56],{"name":57,"role":35,"phone":26,"phoneExt":26,"email":26},"Di Gu, PhD",{"facility":59,"status":26,"city":60,"state":61,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"First Affiliated Hospital and Medical College of Soochow University","Suzhou","Jiangsu",{"type":50,"coordinates":63},[64,65],120.59538,31.30408,{"lat":65,"lon":64},[68],{"name":69,"role":35,"phone":26,"phoneExt":26,"email":26},"Xiang Ding, PhD",{"facility":71,"status":26,"city":72,"state":61,"zip":73,"country":47,"countryCode":48,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Jiangnan University Medical Center","Wuxi","210009",{"type":50,"coordinates":75},[76,77],120.28857,31.56887,{"lat":77,"lon":76},[80],{"name":81,"role":35,"phone":26,"phoneExt":26,"email":26},"Ninghan Feng, PhD",{"facility":83,"status":26,"city":84,"state":85,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"The First Affiliated Hospital of Ningbo University","Ningbo","Zhejiang",{"type":50,"coordinates":87},[88,89],121.54945,29.87819,{"lat":89,"lon":88},[92],{"name":93,"role":35,"phone":26,"phoneExt":26,"email":26},"Zejun Yan, PhD",{"facility":95,"status":26,"city":96,"state":26,"zip":97,"country":47,"countryCode":48,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"The Second Affiliated Hospital of Naval Medical University","Shanghai","200003",{"type":50,"coordinates":99},[100,101],121.45806,31.22222,{"lat":101,"lon":100},[104],{"name":105,"role":35,"phone":106,"phoneExt":26,"email":107},"Shancheng Ren, PhD","021-81885721","renshancheng@gmail.com",{"facility":109,"status":26,"city":96,"state":26,"zip":110,"country":47,"countryCode":48,"cosmosGeoPoint":111,"geoPoint":113,"contacts":114},"The First Affiliated Hospital of Naval Medical University","200433",{"type":50,"coordinates":112},[100,101],{"lat":101,"lon":100},[115],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},{"type":117,"investigatorFullName":118,"investigatorTitle":119,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Zhang Huo Jun","Director","100493616","neoadjuvant-radiohormonal-therapy-for-oligometastatic-prostate-cancer-100493616",false,"NCT05707468","Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer","Safety and Efficacy Study of Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer: a Multi-center Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate without small cell features\n* Oligometastatic PCa assessed by Ga-68 prostate-specific membrane antigen (PSMA), PET\u002FCT\n* \\\u003C4 bone oligometastases, lymph node metastasis below the renal artery level\n* Expected survival time \\>5 years\n* World Health Organization (WHO) performance status 0-1\n* Be willing to give written informed consent.\n\nExclusion Criteria:\n\n* Any previous or ongoing treatment for PCa, including radiotherapy, ADT, chemotherapy, focal treatment, etc.\n* Patients who have previously undergone transurethral resection or enucleation of the prostate.\n* Patients who have undergone other abdominal surgery within the last 3 months\n* Patients who have visceral metastases\n* Patients with a history of long-term anticoagulant use and anti-platelet drug use and who stopped anticoagulant therapy less than 1 week before registration\n* Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and\u002For positive syphilis\n* Severe or active comorbidities likely to impact the advisability of radiotherapy\n* Any other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which, according to the judgement of the investigator, may affect the planned staging, treatment and follow-up or patient compliance or may cause high-risk treatmentrelated complications for the patient\n* Patients who have participated in other clinical trials within the last 3 months\n* Patients who refuse to undergo RALP\n* Patients unsuitable for participation in this clinical trial as per the judgement of the investigator.","MALE","18 Years","75 Years",{"count":131,"type":132},200,"ESTIMATED","INTERVENTIONAL",[135],"NA","The optimal treatment for oligometastatic prostate cancer (OMPC) is still on its way. Accumulating evidence has proven the safety and feasibility of radical prostatectomy and local or metastasis-directed radiotherapy for oligometastatic patients. The aim of this trial is to compare the safety and feasibility outcomes of metastasis-directed neoadjuvant radiotherapy (naRT) and neoadjuvant androgen deprivation therapy (naADT) followed by robotic-assisted radical prostatectomy (RARP) to ADT combined with abiraterone for treating OMPC.",[138],"Oligometastatic Prostate Carcinoma","NOT_YET_RECRUITING","2024-02-19",{"date":142,"type":143},"2024-02-20","ACTUAL",{"date":145,"type":132},"2024-05-01",{"date":147,"type":132},"2028-03-01",{"name":5,"class":6},6]