[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567264":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":27,"responsibleParty":56,"collaborators":11,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":11,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":11,"enrollmentInfo":66,"targetDuration":11,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University Hospital Ostrava","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Men with prostate cancer","EXPERIMENTAL",null,[13],"Procedure: Stereotactic radiotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"PROCEDURE","Stereotactic radiotherapy","Stereotactic surgery is a minimally invasive form of surgical intervention that makes use of a three-dimensional coordinate system to locate small targets inside the body and to perform on them some action such as ablation, biopsy, lesion, injection, stimulation, implantation, radiosurgery, etc.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"Jiří Hynčica","CONTACT","0042059737","2587","jiri.hyncica@fno.cz",[28],{"facility":5,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":11,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RECRUITING","Ostrava","Moravian-Silesian Region","708 52","Czechia",{"type":35,"coordinates":36},"Point",[37,38],18.28204,49.83465,{"lat":38,"lon":37},[41,42,45,48,50,52,54],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},{"name":43,"role":44,"phone":11,"phoneExt":11,"email":11},"Zuzana Zděblová-Čermáková, MD, Ph.D.","PRINCIPAL_INVESTIGATOR",{"name":46,"role":47,"phone":11,"phoneExt":11,"email":11},"Tomáš Blažek, MD, Ph.D.","SUB_INVESTIGATOR",{"name":49,"role":47,"phone":11,"phoneExt":11,"email":11},"Lukáš Knybel, Ing., Ph.D.",{"name":51,"role":47,"phone":11,"phoneExt":11,"email":11},"Pavla Benýšková, Mgr., Ph.D.",{"name":53,"role":47,"phone":11,"phoneExt":11,"email":11},"Zuzana Růžičková, MD",{"name":55,"role":47,"phone":11,"phoneExt":11,"email":11},"Pavla Hanzlíková, MD, Ph.D., MBA",{"type":57,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100567264","stereotactic-radiotherapy-of-prostate-cancer-with-reduction-of-safety-margins-100567264",false,"NCT06665932","Stereotactic Radiotherapy of Prostate Cancer With Reduction of Safety Margins","Inclusion Criteria:\n\n* histologically verified, localized prostate cancer without regional lymphadenopathy or distant metastases\n* low or intermediate risk - favorable risk\n* staging according to NCCN recommendations:\n* low risk: no staging required\n* intermediate risk- favorable risk: CT abdomen and pelvis\n* PSA up to 15\n* age over 18 years\n* signed informed consent form\n* suitable position of fiducials (to be determined by the physicist)\n\nExclusion Criteria:\n\n* a histological type other than acinar adenocarcinoma\n* the presence of local lymphadenopathy or distant metastases\n* a dominant lesion in the periphery that is in contact with the capsule or grows through it\n* PSA over 15\n* unsatisfactory position of fiducials (to be determined by the physicist)\n* previous treatment with radiotherapy to the pelvic area","MALE","18 Years",{"count":67,"type":68},100,"ESTIMATED","INTERVENTIONAL",[71],"NA","The study aims to reduce the PTV (Planning Target Volume) safety margins to 1-2 mm in stereotactic prostate radiotherapy for low- and medium-risk prostate cancers while maintaining a dose of 36.25 Gy in 5 fractions per day. By reducing the hems, the investigators expect a reduction of acute and late toxicity on the organs at risk, dominantly the urethra, bladder, penile bulb, and rectum, and an improvement in the quality of life.",[74],"Prostate Cancer (Adenocarcinoma)",[76,77,78,79],"prostate cancer","Stereotactic Body Radiotherapy","acute toxicity","late toxicity","2024-11-07",{"date":82,"type":83},"2024-11-12","ACTUAL",{"date":85,"type":68},"2024-11-01",{"date":87,"type":68},"2027-12-31",{"name":5,"class":6},1]