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Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial
Sponsor: Mayo Clinic
Summary
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). It also studies the effects of salvage radiation therapy (sXRT) on prostate cancer and to see if radiation to the pelvis helps prevent prostate cancer from spreading elsewhere. 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. sXRT is a targeted radiation treatment for the prostate, typically given when cancer possibly returns after surgery or radiation. Its goal is to destroy any tumor cells in the area. Giving SBRT alone with watchful waiting may be as effective in treating prostate cancer as giving SBRT together with ARPI and ADT and sXRT may be effective in treating prostate cancer and preventing it from spreading elsewhere.
Official title: MC230502 Dynamic Investigator Initiated Enterprise (DIVINE) in Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
532
Start Date
2024-06-03
Completion Date
2029-05-31
Last Updated
2025-12-26
Healthy Volunteers
No
Conditions
Interventions
Abiraterone
Given abiraterone
Apalutamide
Given apalutamide
Biospecimen Collection
Undergo blood sample collection
Bone Scan
Undergo bone scan
Computed Tomography
Undergo CT
Darolutamide
Given darolutamide
Degarelix
Given degarelix
Enzalutamide
Given enzalutamide
Goserelin
Given goserelin
Histrelin
Given histrelin
Leuprolide
Given leuprolide
Magnetic Resonance Imaging
Undergo MRI
Patient Observation
Undergo watchful waiting or initial observation
Positron Emission Tomography
Undergo PET
Prednisone
Given prednisone
Questionnaire Administration
Ancillary studies
Relugolix
Given relugolix
Stereotactic Body Radiation Therapy
Undergo SBRT
Triptorelin
Given triptorelin
Radiation Therapy
Undergo sXRT
Image-Guided Therapy
Undergo image-guided therapy
Locations (3)
Mayo Clinic in Arizona
Phoenix, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States