nctId: NCT06325046 id: 23-003388 id: NCI-2024-01669 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: GMROR2351 type: OTHER domain: Mayo Clinic Radiation Oncology 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 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-06 date: 2026-06 date: 2024-03-22 date: 2024-04-01 name: Mayo Clinic class: OTHER 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. 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 144 type: ESTIMATED name: Computed Tomography name: Cone-Beam Computed Tomography name: Image-Guided Adaptive Radiation Therapy name: Magnetic Resonance Imaging name: Stereotactic Ablative Radiotherapy name: Survey Administration measure: Treatment-related, patient-reported early quality of life (QOL) changes measure: Treatment-related, patient-reported late QOL changes measure: Incidence of grade ≥ 2 genitourinary an/or gastrointestinal adverse events measure: Change in International Index of Erectile Function (IIEF) measure: Change in International Prostate Symptom Score (IPSS) measure: Change in financial adverse events - COST-FACIT measure: Fiducial-free treatment measure: Bladder filling measure: Biochemical recurrence measure: Prostate specific antigen (PSA) kinetics measure: Local recurrence measure: Overall survival sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Mark R. Waddle, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False