[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100485386":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":37,"responsibleParty":57,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":55,"enrollmentInfo":74,"targetDuration":55,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":55,"overallStatus":39,"whyStopped":55,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Sunnybrook Health Sciences Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","EXPERIMENTAL","Two weekly fractions of 13.5 Gy",[13],"Radiation: Stereotactic Ablative Body Radiation",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2","ACTIVE_COMPARATOR","Five every other day fractions of 8 Gy",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","Stereotactic Ablative Body Radiation","2 Fraction",[9,15],[26],"SBRT",[28],{"name":29,"affiliation":5,"role":30},"Danny Vesprini, MD","PRINCIPAL_INVESTIGATOR",[32],{"name":29,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","416-480-6100","4806","Danny.Vesprini@sunnybrook.ca",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Toronto","Ontario","M4N3M5","Canada","CA",{"type":46,"coordinates":47},"Point",[48,49],-79.39864,43.70643,{"lat":49,"lon":48},[52],{"name":53,"role":33,"phone":54,"phoneExt":55,"email":56},"Daniel Vesprini, MD","4164804806",null,"danny.vesprini@sunnybrook.ca",{"type":30,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"Dr. Danny Vesprini","Radiation Oncologist",[61],{"name":62,"class":63},"Prostate Cure Foundation","UNKNOWN","100485386","improving-sexual-quality-of-life---randomized-trial-of-two-vs-five-mri-guided-sabr-treatments-for-prostate-cancer-100485386",false,"NCT05600400","Improving Sexual Quality of Life - Randomized Trial of Two vs Five MRI Guided SABR Treatments for Prostate Cancer","Improving Sexual Quality of Life - A Phase 2 Randomized Controlled Trial of Two Versus Five Stereotactic MRI-Guided Ablative Radiotherapy Treatments for Prostate Cancer","iSMART","Inclusion Criteria:\n\n1. Histologically confirmed prostate adenocarcinoma (centrally reviewed)\n2. Low or favorable intermediate risk disease. Patient must meet one of the following categories:\n\n   * Low risk - T1-T2b, grade group 1, AND PSA \\\u003C 10 ng\u002Fml;\n   * Favorable risk\n\n     1. Only one of the following intermediate risk factors - cT2c, grade group 2, or PSA 10-20 ng\u002Fml; or\n     2. Grade group 3 AND PSA \\\u003C 20, AND \\\u003CcT2c AND absolute percentage pattern 4\u002F5 is \\\u003C10%\n\nExclusion Criteria:\n\n1. Androgen deprivation therapy (LHRH-agonists or antiandrogens) given or planned\n2. Prior pelvic radiotherapy\n3. Anticoagulation medication (if unsafe to discontinue for gold seed insertion)\n4. Diagnosis of bleeding diathesis\n5. Large prostate (\\>90cm3) on imaging\n6. Immunosuppressive medications\n7. Inflammatory bowel disease\n8. Presence of dual hip prostheses\n9. Contraindications to having MRI","MALE","18 Years",{"count":75,"type":76},144,"ESTIMATED","INTERVENTIONAL",[79],"NA","Prostate Stereotactic ablative body radiotherapy (SABR) is an established technique that delivers radiation in a non-invasive approach for men with prostate cancer. The treatment regimen is given in total of 5 fractions with one treatment per day at every other day or weekly sessions. Ultra-hypofractionated radiotherapy (UHRT) is an emerging monotherapy for localized prostate cancer however, several trials have observed demonstrating superior biochemical control of a two-fraction (HDR) over single-fraction approach. The study aims to compare an experimental shorter course of prostate ultra-hypofractionated radiotherapy (UHRT) that will deliver what is expected to be an equivalent amount of radiation as given in the standard 5 treatment regimen. UHRT is given in 2 treatments with one treatment a week for 2 consecutive weeks.",[82,83,84],"Prostate Cancer","Cancer of Prostate","Prostate Adenocarcinoma","2025-09-02",{"date":87,"type":88},"2025-09-09","ACTUAL",{"date":90,"type":88},"2024-03-01",{"date":92,"type":76},"2029-06",{"name":5,"class":6},1]