[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646413":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":70,"collaborators":20,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":20,"enrollmentInfo":84,"targetDuration":20,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SIB-VMAT radiation therapy","EXPERIMENTAL","Patients with histopathologically confirmed prostatic adenocarcinoma staged as high-risk \u002F very high-risk localized disease will receive radiotherapy using Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT) over a total duration of 4 weeks (20 consecutive working days).\n\nTarget volumes:\n\nPTV-1 (PTV 44 Gy) Prostate + Pelvic Lymph Node PTV (PLNI): 44 Gy delivered in 20 fractions (2.2 Gy\u002Ffraction), including the internal iliac, external iliac, obturator, presacral nodal stations, whole prostate, and SV.\n\nPTV-2 (PTV 60 GY): 60 Gy delivered in 20 fractions (3 Gy\u002Ffraction), including the whole prostate and the base of the SV (proximal 1 cm).\n\nSystemic Therapy is allowed during the study when indicated. Patients will receive long-term Androgen Deprivation Therapy (ADT) for a duration of 18-24 months. ADT will be initiated as neoadjuvant therapy 2-3 months prior to the commencement of radiotherapy.",[13],"Radiation: Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT)","Patients with histopathologically confirmed prostatic adenocarcinoma staged as high-risk \u002F very high-risk localized disease will receive radiotherapy using Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT) over a total duration of 4 weeks (20 consecutive working days). Target volumes: PTV-1 (PTV 44 Gy) Prostate + Pelvic Lymph Node PTV (PLNI): 44 Gy delivered in 20 fractions (2.2 Gy\u002Ffraction), including the internal iliac, external iliac, obturator, presacral nodal stations, whole prostate, and SV. PTV-2 (PTV 60 GY): 60 Gy delivered in 20 fractions (3 Gy\u002Ffraction), including the whole prostate and the base of the SV (proximal 1 cm). Systemic Therapy is allowed during the study when indicated. Patients will receive long-term Androgen Deprivation Therapy (ADT) for a duration of 18-24 months. ADT will be initiated as neoadjuvant therapy 2-3 months prior to the commencement of radiotherapy.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Mohamed Alhefny, MD","CONTACT","+201228169673","Alhefny@med.asu.edu.eg",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Ahmed Sohaib, MD","+201060406063","dr.ahmed.sohaib@gmail.com",[32,47,57],{"facility":33,"status":34,"city":35,"state":20,"zip":20,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Faculty of Medicine, Ain Shams University","RECRUITING","Cairo","Egypt","EG",{"type":39,"coordinates":40},"Point",[41,42],31.24967,30.06263,{"lat":42,"lon":41},[45],{"name":46,"role":24,"phone":25,"phoneExt":20,"email":26},"Mohamed Alhefny Almashtouly, MD",{"facility":48,"status":34,"city":49,"state":20,"zip":20,"country":36,"countryCode":37,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"Faculty of Medicine - Menoufia University","Shibīn al Kawm",{"type":39,"coordinates":51},[52,53],31.00904,30.55258,{"lat":53,"lon":52},[56],{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},{"facility":58,"status":34,"city":59,"state":20,"zip":20,"country":36,"countryCode":37,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Faculty of Medicine - Sohag University","Sohag",{"type":39,"coordinates":61},[62,63],31.69478,26.55695,{"lat":63,"lon":62},[66],{"name":67,"role":24,"phone":68,"phoneExt":20,"email":69},"Alshaymaa Abdelghaffar, MD","+201006828975","alshimaaahmed@med.sohag.edu.eg",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Mohamed Alhefny Almashtouly","Lecturer","100646413","phase-2-efficacy-and-safety-of-simultaneous-integrated-boost-radiotherapy-in-hrvhr-prostate-cancer-with-eplni-100646413",false,"NCT07693075","Efficacy and Safety of Simultaneous Integrated Boost Radiotherapy in HR\u002FVHR Prostate Cancer With EPLNI","Prospective Evaluation of Efficacy and Safety of Simultaneous Integrated Boost (SIB-VMAT) Radiotherapy in HR\u002FVHR Prostate Cancer With EPLNI","SIB-VMAT","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate.\n* Classification as High-Risk (HR) or Very High-Risk (VHR) per NCCN guidelines (e.g., T3a+, PSA \\> 20 ng\u002FmL, or Gleason Score 8-10).\n* Adequate baseline urinary function (IPSS \\\\le 20).\n* Multiparametric MRI of the prostate.\n* CT Chest, Abdomen, and Pelvis.\n* Bone scan\n* Optional: PSMA-PET\u002FCT to definitively exclude distant metastases (M1) and provide high-fidelity nodal assessment prior to treatment planning.\n\nExclusion Criteria:\n\n* Prior pelvic radiotherapy.\n* History of Inflammatory Bowel Disease (IBD) or active severe proctitis.\n* Presence of distant metastases.","MALE","18 Years",{"count":85,"type":86},30,"ESTIMATED","INTERVENTIONAL",[89],"PHASE2","The aim of this study is to evaluate the efficacy and safety of hypofractionated simultaneous integrated boost volumetric arc radiation therapy (SIB - VMAT) for high-risk and very high-risk localized prostate cancer in terms of:\n\n1. Acute and late gastrointestinal and genitourinary toxicities.\n2. Evaluate the efficacy in terms of early bPFS.\n3. Dosimetric evaluation in terms of target coverage and organs at risk sparing",[92],"Prostate Cancer Patients Treated by Radiotherapy",[94,95],"SIB-VMAT Radiotherapy","High risk prostate cancer","2026-07-03",{"date":98,"type":99},"2026-07-09","ACTUAL",{"date":101,"type":99},"2025-08-01",{"date":103,"type":86},"2026-11-01",{"name":5,"class":6},3]