[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579499":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":24,"locations":31,"responsibleParty":48,"collaborators":23,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":23,"enrollmentInfo":59,"targetDuration":23,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":23,"overallStatus":34,"whyStopped":23,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Non-adaptive image-guided SBRT","Patients will receive prostate SBRT. A dose of either 36.25 Gy in 5 fractions (per PACE-B trial) or 42.7 Gy in 7 fractions (per HYPO-RT-PC trial) will be prescribed as per standard practice at PMH. Patients will receive SBRT every other day, excluding weekends and holidays, as per standard practice. Patients will undergo radiotherapy simulation as per standard practice with CT and MR simulation (or without MR if contraindication).",[12],"Radiation: SBRT",{"label":14,"type":6,"description":15,"interventionNames":16},"Adaptive SBRT","Patients will receive prostate SBRT. A dose of either 36.25 Gy in 5 fractions (per PACE-B trial) or 42.7 Gy in 7 fractions (per HYPO-RT-PC trial) will be prescribed as per standard practice. Patients will receive SBRT every other day, excluding weekends and holidays, as per standard practice. Patients will undergo radiotherapy simulation as per standard practice with CT and MR simulation (or without MR if contraindication).",[12],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"RADIATION","SBRT","Standard of care SBRT (36.25 Gy in 5 fractions or 42.7 Gy in 7 fractions) for localized prostate cancer, delivered either via an adaptive or a non-adaptive image-guided treatment. Androgen deprivation therapy use and duration is at the discretion of the treating physician and patient, in accordance with standard practice based on patients' prostate cancer risk group.",[14,9],null,[25],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},"Rachel Glicksman, MD","CONTACT","416-946-4559","4961","rachel.glicksman@uhn.ca",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Princess Margaret Cancer Center","RECRUITING","Toronto","Ontario","M5G 2M9","Canada","CA",{"type":41,"coordinates":42},"Point",[43,44],-79.39864,43.70643,{"lat":44,"lon":43},[47],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},{"type":49,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100579499","phase-3-is-adaptive-sbrt-for-prostate-vs-image-guided-radiotherapy-a-true-evolution-aspire-100579499",false,"NCT06825091","Is Adaptive SBRT for Prostate vs Image-guided Radiotherapy a True Evolution (ASPIRE)","ASPIRE","Inclusion Criteria:\n\n1. Age \\>18 years\n2. Histologic diagnosis of prostate adenocarcinoma\n3. Localized prostate cancer\n4. Low risk, intermediate risk, or high risk allowed\n5. Patient planned for prostate SBRT\n\nExclusion Criteria:\n\n1. Planned for elective nodal irradiation\n2. Contraindications to radiotherapy\n3. Patients with bilateral hip replacements, as they are ineligible for adaptive treatments at present time (either MR-guided or CT-guided)","MALE","18 Years",{"count":60,"type":61},320,"ESTIMATED","INTERVENTIONAL",[64],"PHASE3","The ASPIRE study is a Phase III randomized, single-center study designed to evaluate whether adaptive stereotactic body radiotherapy (SBRT) offers superior clinical benefits compared to standard image-guided SBRT for patients with localized prostate cancer. It aims to explore whether adaptive SBRT can improve urinary outcomes while maintaining effective cancer control.\n\nThis interventional study is randomized, single-institution, and includes 320 participants with localized prostate cancer. Patients will be stratified based on fractionation schedules (5 vs. 7 fractions), use of rectal spacers, androgen deprivation therapy (ADT), and baseline alpha receptor antagonist use. Participants will be randomized to receive either adaptive SBRT or standard image-guided SBRT, with both arms adhering to established dosing protocols.\n\nInclusion criteria includes an age greater than 18 years, diagnosed with localized prostate adenocarcinoma, and an ECOG performance status of 0-1, Eligible for prostate SBRT. The exclusion criteria includes patients who plan for elective nodal irradiation and contraindications to radiotherapy or MRI (for MR-Linac patients).",[67,68],"Localized Prostate Cancer","Stereotactic Body Radiotherapy","2026-05-29",{"date":71,"type":72},"2026-06-02","ACTUAL",{"date":74,"type":72},"2025-02-04",{"date":76,"type":61},"2030-02-04",{"name":5,"class":6},1]