[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100440057":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":24,"locations":28,"responsibleParty":49,"collaborators":24,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":24,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":24,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":30,"whyStopped":24,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Shanghai Proton and Heavy Ion Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"carbon ion irradation group","ACTIVE_COMPARATOR","All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle",[13],"Radiation: carbon ion irradation",{"label":15,"type":10,"description":16,"interventionNames":17},"Carbon Ion Irradiation With SIB group","All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle, and with simultaneous integrated boost (SIB) to the gross tumor in the PSMA PET\u002FCT and mpMRI",[18],"Radiation: Carbon Ion Irradiation With SIB",[20,25],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"RADIATION","carbon ion irradation",[9],null,{"type":21,"name":26,"description":16,"armGroupLabels":27,"otherNames":24},"Carbon Ion Irradiation With SIB",[15],[29],{"facility":5,"status":30,"city":31,"state":24,"zip":24,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RECRUITING","Shanghai","China","CN",{"type":35,"coordinates":36},"Point",[37,38],121.45806,31.22222,{"lat":38,"lon":37},[41,46],{"name":42,"role":43,"phone":44,"phoneExt":24,"email":45},"Ping Li","CONTACT","38296666","ping.li@sphic.org.cn",{"name":47,"role":43,"phone":44,"phoneExt":24,"email":48},"Qing Zhang","qing.zhang@sphic.org.cn",{"type":50,"investigatorFullName":42,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100440057","phase-2-functional-image-guided-carbon-ion-irradiation-with-simultaneous-integrated-boost-for-prostate-cancer-100440057",false,"NCT05010343","Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer","Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer: a Phase II Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Pathologically confirmed adenocarcinoma of prostate\n* Stage cT1-3N0M0 localized prostate cancer\n* performed PSMA PET\u002FCT and mpMRI before treatment\n* No lymph nodes or distant metastasis\n* Age ≥ 45 and \\\u003C 85 years of age\n* Karnofsky Performance Score ≥70\n* No previous pelvic radiation therapy (RT)\n* No previous prostatectomy\n* No previous invasive cancer (within 5 years before the prostate cancer diagnosis)\n* Ability to understand character and individual consequences of the clinical trial\n* Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial\n\nExclusion Criteria:\n\n* No pathologically confirmed adenocarcinoma of the prostate\n* Pelvic lymph node metastasis (N1)\n* Distant metastasis (M1)\n* Previous pelvic radiotherapy\n* Previous prostatectomy","MALE","45 Years","85 Years",{"count":63,"type":64},140,"ESTIMATED","INTERVENTIONAL",[67],"PHASE2","This is a phase II randomized controlled clinical trial to assess the toxicities and clinical efficacy of prostate specific membrane antigen (PSMA) positron emission tomography \u002F computed tomography (PET\u002FCT) and multi- parameter Magnetic Resonance Imaging (MRI) guided simultaneous integrated boost for prostate cancer.",[70],"Localized Prostate Cancer",[72,73,74,75],"carbon ion irradiation","Simultaneous Integrated Boost","PSMA PET\u002FCT","mpMRI","2021-11-12",{"date":78,"type":79},"2021-11-15","ACTUAL",{"date":81,"type":79},"2020-10-15",{"date":83,"type":64},"2028-07-01",{"name":5,"class":6},1]