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.
Age ≥ 18 years
Clinical confirmation of metachronous (metastatic) recurrent hormone-sensitive prostate cancer
Five (5) or fewer metastases with at least one metastasis beyond the pelvis on advanced molecular and/or conventional imaging
Serum testosterone > 100ng/dL or clinically deemed non-castrate
Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown
Pregnant persons
Nursing persons
Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception
Parallel
Abiraterone
DrugGiven abiraterone
Apalutamide
DrugGiven apalutamide
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Bone Scan
Procedure/SurgeryUndergo bone scan
Computed Tomography
Procedure/SurgeryUndergo CT
Darolutamide
DrugGiven darolutamide
Degarelix
DrugGiven degarelix
Enzalutamide
DrugGiven enzalutamide
Goserelin
DrugGiven goserelin
Histrelin
DrugGiven histrelin
Leuprolide
DrugGiven leuprolide
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Patient Observation
Other interventionUndergo watchful waiting or initial observation
Positron Emission Tomography
Procedure/SurgeryUndergo PET
Prednisone
DrugGiven prednisone
Questionnaire Administration
Other interventionAncillary studies
Relugolix
DrugGiven relugolix
Stereotactic Body Radiation Therapy
RadiationUndergo SBRT
Triptorelin
DrugGiven triptorelin
Radiation Therapy
RadiationUndergo sXRT
Image-Guided Therapy
Procedure/SurgeryUndergo image-guided therapy
Modified radiographic progression-free survival (mrPFS) (Groups A & B)
Modified radiographic progression-free survival (mrPFS) is defined as the time from the date of randomization (enrollment to study) to the date of the first occurrence of the following events: death due to all causes or radiographic progression per Prostate Cancer Working Group 3 Criteria, which is not addressable by stereotactic body radiation therapy (SBRT). Radiographic progression not addressable by SBRT per the treating physician NOTE: Radiographic progression disease that can be addressed by SBRT will not be an mrPFS event. NOTE: Event-free patients will be censored at their last imaging assessment.
Distant progression-free survival (PFS) (Groups C & D)
Defined as the date from the date of randomization + 1 year to the date of the first occurrence of death due to all causes or distant progression. Local progression will NOT be considered a distant progression event. Event-free patients will be censored at their last imaging assessment or prostate-specific antigen evaluation, whichever is later.
Overall survival (OS)
Defined as time from randomization (enrolled to study) to the date of death due to any cause. Will be conducted on modified intent-to-treat (mITT) and per-protocol (PP) populations whenever it is applicable and plausible. Safety-related analyses will be performed on the safety population.
Biochemcial progression-free survival (bPFS)
Defined as the time from randomization (enrollment to study) up to the date of death due to any cause or biochemical progressive disease, whichever occurs first. Will be conducted on mITT and PP populations whenever it is applicable and plausible. Safety-related analyses will be performed on the safety population.
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Mayo Clinic
Lead sponsor
National Cancer Institute (NCI)
Collaborator
