[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053561":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":28,"responsibleParty":46,"collaborators":20,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":20,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":20,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"National Cancer Center, Korea","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ultrahypofractionated proton beam therapy","EXPERIMENTAL","Participants receive definitive ultrahypofractionated proton beam therapy (35-40 Gy\\[RBE\\] in 5 fractions) for localized prostate adenocarcinoma using image-guided proton therapy. Participants are prospectively followed for oncologic outcomes, treatment-related toxicity, and patient-reported quality of life.",[13],"Radiation: Ultrahypofractionated Proton Beam Therapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","Ultrahypofractionated Proton Beam Therapy","Ultrahypofractionated proton beam therapy is delivered using pencil beam scanning (PBS) with image-guided proton therapy. Before treatment planning, all participants undergo placement of an absorbable rectal hydrogel spacer and two intraprostatic gold fiducial markers. Treatment planning is performed using CT simulation with MRI fusion after hydrogel stabilization. Daily cone-beam CT (CBCT) with fiducial marker matching is used for image guidance and patient positioning. A total dose of 36.25-40.0 Gy(RBE) is delivered in 5 fractions over approximately 1-2 weeks. Unlike conventional proton beam therapy using opposed right and left lateral beam arrangements, this protocol employs four oblique beam angles (right anterior oblique, right posterior oblique, left posterior oblique, and left anterior oblique) to optimize dose conformity while minimizing radiation exposure to adjacent normal tissues.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},"Hyuna Park Clinical Research Coordinator, BS","CONTACT","82-31-920-0491","0491","77313@ncc.re.kr",[29],{"facility":5,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":20,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"RECRUITING","Goyang-si","Gyeonggi-do","10408","South Korea",{"type":36,"coordinates":37},"Point",[38,39],126.835,37.65639,{"lat":39,"lon":38},[42],{"name":43,"role":24,"phone":44,"phoneExt":20,"email":45},"Sung Uk Lee, M.D., Ph.D.","82-31-920-1720","sulee126@ncc.re.kr",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Sung Uk Lee","Clinical staff","100053561","prospective-study-of-ultrahypofractionated-proton-beam-therapy-for-localized-prostate-cancer-100053561",false,"NCT07699705","Prospective Study of Ultrahypofractionated Proton Beam Therapy for Localized Prostate Cancer","Prospective Cohort Study for Identifying Factors Predicting Long-term Outcomes of Prostate Cancer Patients Who Received Ultrahypofractionated Proton Beam Therapy","Inclusion Criteria:\n\n* Histologically confirmed localized adenocarcinoma of the prostate.\n* No evidence of distant metastasis (M0).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Eligible to receive definitive image-guided ultrahypofractionated pencil beam scanning proton beam therapy according to the study protocol.\n* Ability to complete study questionnaires and comply with scheduled follow-up assessments.\n* Provision of written informed consent before study enrollment.\n\nExclusion Criteria:\n\n* Residual or recurrent prostate cancer following prior radical prostatectomy.\n* Previous pelvic radiotherapy.\n* Evidence of distant metastatic disease.\n* Active malignancy within the previous 1 year, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or completely resected T1N0M0 malignancies.\n* Uncontrolled psychiatric illness, severe traumatic brain injury, chronic alcohol or substance dependence, or other medical conditions that, in the investigator's judgment, would preclude safe participation or adequate follow-up.\n* Inability or unwillingness to provide written informed consent or comply with study procedures.","MALE","19 Years",{"count":60,"type":61},50,"ESTIMATED","INTERVENTIONAL",[64],"NA","The goal of this prospective observational cohort study is to evaluate the long-term efficacy and safety of ultrahypofractionated proton beam therapy in patients with localized prostate cancer and to identify clinical and treatment-related factors associated with oncologic outcomes and treatment-related toxicity.\n\nThe main questions it aims to answer are:\n\nWhat are the long-term biochemical recurrence-free survival, clinical progression-free survival, overall survival, and acute and late treatment-related toxicity outcomes following ultrahypofractionated proton beam therapy? Which clinical characteristics, treatment planning parameters, and patient-reported outcomes are predictive of long-term oncologic outcomes and treatment-related toxicity?\n\nParticipants will:\n\nReceive protocol-based ultrahypofractionated proton beam therapy (35-40 Gy\\[RBE\\] in 5 fractions).\n\nUndergo routine clinical evaluation, laboratory testing including prostate-specific antigen (PSA), and imaging studies according to the institutional follow-up schedule.\n\nComplete patient-reported outcome questionnaires (EPIC-CP and Visual Analog Scale \\[VAS\\]) before treatment and during follow-up.\n\nBe followed prospectively to assess biochemical recurrence, clinical progression, survival outcomes, and acute and late treatment-related toxicities.",[67],"Prostate Neoplasm",[69,70],"prostate neoplasm","proton therapy","2026-07-09",{"date":73,"type":74},"2026-07-13","ACTUAL",{"date":76,"type":74},"2024-11-04",{"date":78,"type":61},"2034-12-31",{"name":5,"class":6},1]