[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100378835":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":20,"interventions":27,"overallOfficials":33,"centralContacts":38,"locations":43,"responsibleParty":59,"collaborators":13,"id":62,"slug":13,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":13,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":13,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":13,"overallStatus":46,"whyStopped":13,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"King Saud University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Acute Toxicity","To document the rate of acute urinary and bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) criteria","3 month after accrual is completed",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE",[21],{"label":22,"type":23,"description":24,"interventionNames":25},"Experimental arm","EXPERIMENTAL","SABR 35Gy\u002F5 to prostate, up to 50Gy\u002F5 to MR nodule, and 25Gy\u002F5 to pelvic nodes and SVs",[26],"Radiation: Pelvic SABR with intra-prostatic SABR",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":13},"RADIATION","Pelvic SABR with intra-prostatic SABR","SABR 25Gy \u002F 5 fractions to pelvis; 35Gy \u002F 5 fractions to prostate; up to 50Gy \u002F 5 fractions to MR nodule",[22],[34],{"name":35,"affiliation":36,"role":37},"Yasir Alayed, MD","King Saud Medical City","PRINCIPAL_INVESTIGATOR",[39],{"name":35,"role":40,"phone":41,"phoneExt":13,"email":42},"CONTACT","+966114671546","yalayed@ksu.edu.sa",[44],{"facility":45,"status":46,"city":47,"state":13,"zip":13,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"King Saud University Medical City","RECRUITING","Riyadh","Saudi Arabia","SA",{"type":51,"coordinates":52},"Point",[53,54],46.72185,24.68773,{"lat":54,"lon":53},[57,58],{"name":35,"role":40,"phone":41,"phoneExt":13,"email":42},{"name":35,"role":37,"phone":13,"phoneExt":13,"email":13},{"type":37,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"Dr. Yasir Alayed","Consultant and Assistant Professor","100378835",false,"NCT04212715","Prostate SABR With Intra-Prostatic SABR Boost","Prostate SABR With Intra-Prostatic SABR Boost: A Phase II Study","Inclusion Criteria:\n\n* Histologically confirmed prostate adenocarcinoma\n* High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA \\> 20 ng\u002FmL\n* Willing to give informed consent to participate in this clinical trial\n\nExclusion Criteria:\n\n* Prior pelvic radiotherapy\n* Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease\n* Contraindication to prostate MRI\n* No evidence of castrate resistance (defined as PSA \\\u003C 3 ng\u002Fml while testosterone is \\\u003C 0.7nmol\u002Fl. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.\n* Definitive extrapelvic nodal or distant metastatic disease on staging investigations.","MALE","18 Years","99 Years",{"count":72,"type":73},30,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","Stereotactic Ablative Radiation (SABR\u002FSBRT) will be prescribed to a dose of 35 Gy in 5 fractions, once weekly to prostate with a simultaneous intra-prostatic boost to the MR detected nodule up to 50Gy. The pelvic lymph nodes and seminal vesicles will also receive 25 Gy in 5 weekly fractions.",[79],"Prostate Cancer","2019-12-27",{"date":82,"type":83},"2020-01-02","ACTUAL",{"date":85,"type":83},"2019-12-26",{"date":87,"type":73},"2026-12",{"name":5,"class":6},1]