NCT06378866 · Mayo Clinic
Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial
(DIVINE)
What this study is about
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
View original scientific description
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).
Interventions
DRUG
Abiraterone
Given abiraterone
DRUG
Apalutamide
Given apalutamide
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
PROCEDURE
Bone Scan
Undergo bone scan
PROCEDURE
Computed Tomography
Undergo CT
DRUG
Darolutamide
Given darolutamide
DRUG
Degarelix
Given degarelix
DRUG
Enzalutamide
Given enzalutamide
DRUG
Goserelin
Given goserelin
DRUG
Histrelin
Given histrelin
DRUG
Leuprolide
Given leuprolide
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
OTHER
Patient Observation
Undergo watchful waiting or initial observation
PROCEDURE
Positron Emission Tomography
Undergo PET
DRUG
Prednisone
Given prednisone
OTHER
Questionnaire Administration
Ancillary studies
DRUG
Relugolix
Given relugolix
RADIATION
Stereotactic Body Radiation Therapy
Undergo SBRT
DRUG
Triptorelin
Given triptorelin
RADIATION
Radiation Therapy
Undergo sXRT
PROCEDURE
Image-Guided Therapy
Undergo image-guided therapy
Primary outcome measures
Modified radiographic progression-free survival (mrPFS) (Groups A & B)
Time frame: 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)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Phoenix, Arizona
- Jacksonville, Florida
- Rochester, Minnesota
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 20, 2026 · Source of record for eligibility and locations