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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexMale
• Healthy volunteersNo

You may be able to join if

• Age ≥ 18 years
• Disease characteristics:
• DEVIATE (Groups A and B only):
• 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
• BRIO (Groups C & D only):
• Prostate-specific antigen (PSA) between 0.15 and 1.5 ng/mL with PSA ≥ 0.15 ng/mL on at least two measurements at least 5 days apart
• No local or metastatic recurrence apparent on advanced molecular imaging
• Serum testosterone > 100 ng/dL or clinically deemed non-castrate
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
• Hemoglobin ≥ 8.0 g/dL (obtained ≤ 15 days prior to registration)
• Absolute neutrophil count (ANC) ≥ 1500/mm^3 (obtained ≤ 15 days prior to registration)
• Platelet count ≥ 80,000/mm^3 (obtained ≤ 15 days prior to registration)
• Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤ 3 x upper limit of normal (ULN) (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)
• Calculated creatinine clearance ≥ 30 ml/min using the Cockcroft-Gault formula (obtained ≤ 15 days prior to registration)
• Provide written informed consent
• Ability to complete questionnaire(s) by themselves or with assistance
• Willingness to provide mandatory blood specimens for correlative research
• Willingness to allow access to provide tissue specimens for correlative research
• Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

You cannot join if

• 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
• Prior metastasis-directed therapy
• Any of the following prior therapies:
• Surgery ≤ 3 weeks prior to registration
• Chemotherapy for prostate cancer at any time
• Androgen receptor pathway inhibitors such as abiraterone, apalutamide, darolutamide, or enzalutamide in the last 2 years
• Uncontrolled intercurrent non-cardiac illness including, but not limited to:
• Ongoing or active infection
• Psychiatric illness/social situations
• Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy
• Any other conditions that would limit compliance with study requirements
• Receiving any other investigational agent which would be considered as a treatment for prostate cancer.
• Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Uncontrolled intercurrent illness including, but not limited to:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• Or psychiatric illness/social situations that would limit compliance with study requirements
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
• Other active malignancy ≤ 3 years prior to registration
• EXCEPTIONS: Curatively treated non-melanotic skin cancer or papillary thyroid cancer
• NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment such as chemotherapy or antihormonal therapy for their cancer
• History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• Abiraterone (Drug): Given abiraterone
• Apalutamide (Drug): Given apalutamide
• Biospecimen Collection (Procedure): Undergo blood sample collection
• Bone Scan (Procedure): Undergo bone scan
• Computed Tomography (Procedure): Undergo CT
• Darolutamide (Drug): Given darolutamide
• Degarelix (Drug): Given degarelix
• Enzalutamide (Drug): Given enzalutamide
• Goserelin (Drug): Given goserelin
• Histrelin (Drug): Given histrelin
• Leuprolide (Drug): Given leuprolide
• Magnetic Resonance Imaging (Procedure): Undergo MRI
• Patient Observation (Other): Undergo watchful waiting or initial observation
• Positron Emission Tomography (Procedure): Undergo PET
• Prednisone (Drug): Given prednisone
• Questionnaire Administration (Other): Ancillary studies
• Relugolix (Drug): Given relugolix
• Stereotactic Body Radiation Therapy (Radiation): Undergo SBRT
• Triptorelin (Drug): Given triptorelin
• Radiation Therapy (Radiation): Undergo sXRT
• Image-Guided Therapy (Procedure): Undergo image-guided therapy

Randomized · Parallel · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• blood samples: Part of the study plan
• CT scans: Part of the study plan
• MRI: Part of the study plan
• PET scans: Part of the study plan
• questionnaires: Part of the study plan
• surgery: Part of the study plan
• radiation: Part of the study plan
• bone scan: Part of the study plan

Main goals

• Modified radiographic progression-free survival (mrPFS) (Groups A & B) (Up to 5 years)
• Distant progression-free survival (PFS) (Groups C & D) (Up to 5 years)

Other goals

• Overall survival (OS)
• Biochemcial progression-free survival (bPFS)

Planned enrollment: 532 (estimated).

• Mayo Clinic in Arizona, Phoenix, Arizona
• Mayo Clinic in Florida, Jacksonville, Florida
• Mayo Clinic in Rochester, Rochester, Minnesota

Site status as of Oct 30, 2026. Check the live record before contacting a site.

These papers are listed in the registry record. Unless a paper is marked as about this trial, it is background research on the treatment or disease, not results from this study.

• Publication about this trial (to be verified before citing)Wei N, Phillips RM, Kwon E, Stish BJ, Ehman EC, Lucien F, O'Byrne J, Bobek O, Shi Q, Andrews JR, Boorjian SA, Park SS, Orme JJ, Sharma V. Biochemical Recurrence Irradiation or Observation (BRIO) in patients with prostate cancer: protocol for a randomised control trial. BJU Int. 2026 Sep;138(3):403-408. doi: 10.1111/bju.70305. Epub 2026 May 12.

• ClinicalTrials.gov NCT06378866

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jul 19, 2026. Public record; not medical advice.