protocolSection identificationModule nctId: NCT06378866, orgStudyIdInfo id: MC230502, secondaryIdInfos id: NCI-2024-02978, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 23-012176, type: OTHER, domain: Mayo Clinic Institutional Review Board, secondaryIdInfos id: MC230502, type: OTHER, domain: Mayo Clinic in Rochester, briefTitle: Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial, acronym: DIVINE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2029-04-30, completionDateStruct date: 2029-04-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This phase II trial studies the effects of stereotactic body radiation therapy (SBRT) and the timing of treatment with androgen receptor pathway inhibitor (ARPI) plus androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread from where it first started to other places in the body (metastatic), and that has come back after a period of improvement (recurrent). SBRT 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. Androgen can cause the growth of prostate cells. ADT lowers the amount of androgen made by the body. This may help stop the growth of tumor cells that need androgen to grow. Androgen receptor pathway inhibitors work by blocking the effects of androgen to stop the growth and spread of tumor cells. Giving SBRT alone with watchful waiting may be as effective in treating prostate cancer as giving SBRT together with ARPI and ADT., conditionsModule conditions: Recurrent Castration-Sensitive Prostate Carcinoma, conditions: Stage IVB Prostate Cancer AJCC v8, conditions: Recurrent Prostate Cancer, conditions: Castration-resistant Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Abiraterone, interventions name: Apalutamide, interventions name: Biospecimen Collection, interventions name: Bone Scan, interventions name: Computed Tomography, interventions name: Darolutamide, interventions name: Degarelix, interventions name: Enzalutamide, interventions name: Goserelin, interventions name: Histrelin, interventions name: Leuprolide, interventions name: Magnetic Resonance Imaging, interventions name: Patient Observation, interventions name: Positron Emission Tomography, interventions name: Prednisone, interventions name: Questionnaire Administration, interventions name: Relugolix, interventions name: Stereotactic Body Radiation Therapy, interventions name: Triptorelin, outcomesModule primaryOutcomes measure: Modified radiographic progression-free survival (mrPFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Biologic progression-free survival (bPFS), secondaryOutcomes measure: Time to local progression (TLP), secondaryOutcomes measure: Time to distant progression (TDP), secondaryOutcomes measure: Adverse event (AE) rate, 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: Jacob J. Orme, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False