protocolSection identificationModule nctId: NCT06325046, orgStudyIdInfo id: 23-003388, secondaryIdInfos id: NCI-2024-01669, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: GMROR2351, type: OTHER, domain: Mayo Clinic Radiation Oncology, secondaryIdInfos id: 23-003388, type: OTHER, domain: Mayo Clinic Institutional Review Board, briefTitle: Evaluating Changes in Quality of Life After Near Margin-less Adaptive Radiation Therapy Compared to Standard Stereotactic Ablative Body Radiotherapy in Localized Prostate Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This clinical trial evaluates changes in quality of life after two treatments with near margin-less adaptive radiation therapy (ART) compared to five treatments with standard stereotactic ablative body radiotherapy (SABR) in patients with prostate cancer that has not spread to other parts of the body (localized). ART is a type of radiation therapy that uses information gathered during the treatment cycle to inform, guide, and alter future radiation treatments with respect to location and dose. It may be able to deliver radiation to the site of disease over a shorter time and with smaller margins (less treatment delivered to nearby healthy tissues). SABR is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Shorter duration near margin-less ART may be just as effective at treating patients with localized prostate cancer but have less quality of life side effects than standard SABR., conditionsModule conditions: Localized Prostate Adenocarcinoma, conditions: Stage I Prostate Cancer AJCC v8, conditions: Stage II Prostate Cancer AJCC v8, conditions: Stage III Prostate Cancer AJCC v8, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: Computed Tomography, interventions name: Cone-Beam Computed Tomography, interventions name: Image-Guided Adaptive Radiation Therapy, interventions name: Magnetic Resonance Imaging, interventions name: Stereotactic Ablative Radiotherapy, interventions name: Survey Administration, outcomesModule primaryOutcomes measure: Treatment-related, patient-reported early quality of life (QOL) changes, secondaryOutcomes measure: Treatment-related, patient-reported late QOL changes, secondaryOutcomes measure: Incidence of grade ≥ 2 genitourinary an/or gastrointestinal adverse events, secondaryOutcomes measure: Change in International Index of Erectile Function (IIEF), secondaryOutcomes measure: Change in International Prostate Symptom Score (IPSS), secondaryOutcomes measure: Change in financial adverse events - COST-FACIT, secondaryOutcomes measure: Fiducial-free treatment, secondaryOutcomes measure: Bladder filling, secondaryOutcomes measure: Biochemical recurrence, secondaryOutcomes measure: Prostate specific antigen (PSA) kinetics, secondaryOutcomes measure: Local recurrence, secondaryOutcomes measure: Overall survival, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Mark R. Waddle, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False