nctId: NCT06378866 id: MC230502 id: NCI-2024-02978 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-012176 type: OTHER domain: Mayo Clinic Institutional Review Board 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 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-04-30 date: 2029-04-30 date: 2024-04-23 date: 2024-04-23 name: Mayo Clinic class: OTHER 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. conditions: Recurrent Castration-Sensitive Prostate Carcinoma conditions: Stage IVB Prostate Cancer AJCC v8 conditions: Recurrent Prostate Cancer conditions: Castration-resistant Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Abiraterone name: Apalutamide name: Biospecimen Collection name: Bone Scan name: Computed Tomography name: Darolutamide name: Degarelix name: Enzalutamide name: Goserelin name: Histrelin name: Leuprolide name: Magnetic Resonance Imaging name: Patient Observation name: Positron Emission Tomography name: Prednisone name: Questionnaire Administration name: Relugolix name: Stereotactic Body Radiation Therapy name: Triptorelin measure: Modified radiographic progression-free survival (mrPFS) measure: Overall survival (OS) measure: Biologic progression-free survival (bPFS) measure: Time to local progression (TLP) measure: Time to distant progression (TDP) measure: Adverse event (AE) rate 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: Jacob J. Orme, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False