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DIVINE Trial: Radiation and Hormone Therapy for Recurrent Prostate Cancer

This study, called the DIVINE Trial, is looking at how stereotactic body radiation therapy (SBRT) combined with hormone-blocking medicines like Abiraterone or Apalutamide, and androgen deprivation therapy (ADT), affects men with prostate cancer that has come back or spread. It also studies if radiation to the pelvis can stop the cancer from spreading further. The study aims to see if these treatments can prevent the cancer from growing or spreading for up to 5 years. You might be able to join if you are a man aged 18 or older with recurrent prostate cancer that is sensitive to hormones and has spread to a few areas outside the pelvis. The study is currently unclear on its recruitment status and plans to enroll 532 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 532 participants.
What's involved
Participants may undergo blood sample collection, bone scans, and CT scans. The study will measure outcomes for up to 5 years.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how long it takes for the cancer to progress for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06378866

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Mayo Clinic
~532 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:AbirateroneApalutamideBiospecimen CollectionBone ScanComputed TomographyDarolutamide

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Modified radiographic progression-free survival (mrPFS) (Groups A & B)
Measured over Up to 5 years
+1 more outcome measured

Conditions

Recurrent Castration-Sensitive Prostate Carcinoma
Recurrent Prostate Cancer
Castration-resistant Prostate Cancer
Biochemically Recurrent Prostate Carcinoma

Explore related trials

Prostate Carcinoma

Where it's being run

3 sites across 3 states
Arizona1
Florida1
Minnesota1

Study leadership

  • Jacob J. Orme, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)

Exclusion

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

What this trial measures

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

    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)Up to 5 years

    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.