[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518234":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":42,"responsibleParty":59,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":25,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":25,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Rabin Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Two-fraction stereotactic radiotherapy","EXPERIMENTAL","Participants receive stereotactic ablative radiotherapy in two treatments to a dose of 27 Gy, with the options to boost a high-grade lesion to 30 Gy",[13],"Radiation: Two-fraction stereotactic radiotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Five-fraction stereotactic radiotherapy","ACTIVE_COMPARATOR","Participants receive stereotactic ablative radiotherapy in five treatments to a dose of 40 Gy, with the options to boost a high-grade lesion to 45 Gy",[19],"Radiation: Five-fraction stereotactic radiotherapy",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","Definitive prostate radiotherapy will be delivered to a dose biologically comparable to 40 Gy in 5 treatments, but in only 2 treatments",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Definitive prostate radiotherapy will be delivered to a standard stereotactic dose of 40 Gy in 5 treatments",[15],[30],{"name":31,"affiliation":32,"role":33},"Elisha T Fredman, MD","Davidoff Cancer Center, Rabin Medical Center","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","9148744461","elishafre@clalit.org.il",{"name":40,"role":36,"phone":25,"phoneExt":25,"email":41},"Assaf Moore, MD","assafmo1@clalit.org.il",[43],{"facility":32,"status":44,"city":45,"state":46,"zip":47,"country":46,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Petah Tikva","Israel","49100","IL",{"type":50,"coordinates":51},"Point",[52,53],34.88747,32.08707,{"lat":53,"lon":52},[56],{"name":57,"role":36,"phone":37,"phoneExt":25,"email":58},"Tal Shlezinger","talzda@clalit.org.il",{"type":60,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100518234","two-fraction-versus-five-fraction-stereotactic-radiotherapy-for-localized-prostate-cancer-100518234",false,"NCT06027892","Two-fraction Versus Five-fraction Stereotactic Radiotherapy for Localized Prostate Cancer","Two-fraction Versus Five-fraction Stereotactic Radiotherapy for Localized Low- and Favorable Intermediate-risk Prostate Cancer: SABR-Dual","SABR-Dual","Inclusion:\n\n* Male patients ≥18 years\n* Diagnosis of low- or favorable intermediate-risk prostate adenocarcinoma\n\n  * T1-T2c\n  * Prostate specific antigen \\\u003C 20\n  * Gleason 6 or 7 (3+4)\n  * Cannot had multiple intermediate-risk factors consistent with unfavorable intermediate risk disease\n* Prostate gland \\\u003C 60 cc (can include following cytoreductive androgen deprivation)\n* International Prostate Symptom Score \\\u003C 15 (unaided by a-adrenergic inhibitor or anticholinergic drugs)\n\nExclusion:\n\n* Unfavorable intermediate-risk disease and above\n* Chronic inflammatory bowel condition (IBD, Crohn's disease, Sarcoidosis, Rheumatic disease)\n* Chronic immunosuppression\n* Contraindications to hydrogel spacer placement\n* Contraindications to a prostate MRI\n* Any prior prostate cancer treatment\n* Prior pelvic radiotherapy\n* Previous transurethral resection of the prostate (TURP) within 12 months\n* Hip prosthesis\n* Prior use of therapeutic androgen deprivation therapy","MALE","18 Years",{"count":72,"type":73},562,"ESTIMATED","INTERVENTIONAL",[76],"NA","The goal of this clinical trial is to compare two dose schedules of stereotactic radiation therapy in patients with localized prostate cancer. Historically, external beam radiation to treat localized prostate cancer was given in small treatments over a period of multiple weeks. Recent studies have shown that with newer technologies and better understanding of how prostate cancer responds to radiation, the same effective dose can be given in as few as 5 treatments. This study is comparing this newer standard course of 5 treatments with an even shorter course of just 2 treatments. The dose for the 2 treatments is based on a form of internal radiation called brachytherapy, but in this study, that dose will be given using external radiation, without the need for invasive procedures.\n\nIn order to make sure that the radiation therapy is given in a way that minimizes the risk of side effects to the surrounding organs, including the rectum and bladder, prior to radiation a hydrogel material will be inserted behind the prostate in order to distance the rectum further from the prostate gland, and small gold markers will be inserted into the prostate to decrease any possible movement during treatment.\n\nThe main questions are whether 2-treatment radiation is tolerated as well and is as effective at treating prostate cancer, compared to the standard 5-treatment course of radiation.",[79],"PROSTATE CANCER","2024-11-13",{"date":82,"type":83},"2024-11-15","ACTUAL",{"date":85,"type":83},"2022-12-29",{"date":87,"type":73},"2032-12",{"name":5,"class":6},1]