Actively Recruiting
Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for Prostate Cancer Treatment, DIVINE Trial
Led by Mayo Clinic · Updated on 2026-04-20
532
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating different treatment strategies for men with hormone-sensitive prostate cancer that has spread to other parts of the body and has returned after initial improvement. This phase II trial compares the effects of stereotactic body radiation therapy (SBRT) combined with androgen receptor pathway inhibitors (ARPI) and androgen deprivation therapy (ADT), against SBRT alone or salvage radiation therapy (sXRT). The study also explores whether radiation to the pelvis helps prevent further spread of the cancer and aims to assess progression-free survival and other important outcomes. Participants are assigned to one of two groups: the DEVIATE cohort or the BRIO cohort. In the DEVIATE cohort, patients receive SBRT plus ARPI and ADT for up to six months followed by watchful waiting, or SBRT with watchful waiting alone. In the BRIO cohort, patients receive salvage radiation therapy with watchful waiting or initial observation with image-guided therapy if progression occurs. Treatments repeat in cycles every 16 weeks without disease progression or unacceptable side effects. Throughout the trial, patients undergo various imaging scans including PET, CT, MRI, and bone scans, as well as blood sample collections. Participants will be closely monitored with regular imaging and blood tests during treatment and follow-up phases. After completing study treatments, patients are followed every six months for up to five years to assess disease progression and survival outcomes. Researchers will also evaluate side effects, biochemical progression, and biomarkers such as extracellular vesicles and circulating tumor DNA to better understand treatment effects and disease behavior.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical confirmation of metachronous recurrent hormone-sensitive prostate cancer with five or fewer metastases, including at least one beyond the pelvis (DEVIATE groups A and B only)
- Serum testosterone greater than 100 ng/dL (DEVIATE and BRIO groups)
- Prostate-specific antigen (PSA) between 0.2 and 1.5 ng/mL with at least two consecutive measurements above 0.2 ng/mL at least 5 days apart (BRIO groups C and D only)
- No local or metastatic recurrence on advanced molecular imaging (BRIO groups C and D only)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Hemoglobin level of 8.0 g/dL or higher within 15 days before registration
- Absolute neutrophil count of 1500/mm³ or higher within 15 days before registration
- Platelet count of 80,000/mm³ or higher within 15 days before registration
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) levels at or below 3 times the upper limit of normal (or 5 times for patients with liver involvement) within 15 days before registration
- Calculated creatinine clearance of 30 ml/min or higher within 15 days before registration
- Ability and willingness to provide written informed consent
- Ability to complete questionnaires independently or with assistance
- Willingness to provide blood and tissue specimens for research
- Willingness to return for follow-up visits during active monitoring phase
You will not qualify if you...
- Pregnant or nursing persons, or persons able to father a child who are unwilling to use adequate contraception
- Prior metastasis-directed therapy
- Surgery within 3 weeks before registration
- Previous chemotherapy for prostate cancer
- Use of androgen receptor pathway inhibitors such as abiraterone, apalutamide, darolutamide, or enzalutamide within the last 2 years
- Uncontrolled non-cardiac illnesses including active infections, psychiatric or social issues, or conditions requiring continuous oxygen therapy
- Receiving other investigational agents for prostate cancer treatment
- Incomplete recovery from prior therapy effects except stable grade 1 peripheral neuropathy for at least 3 months
- Severe co-morbid illnesses or conditions interfering with study participation or safety assessment
- Uncontrolled cardiac illnesses such as symptomatic heart failure, unstable angina, or arrhythmias
- Other active malignancies within 3 years prior to registration except treated non-melanotic skin or papillary thyroid cancers
- History of myocardial infarction within 6 months or congestive heart failure requiring ongoing therapy for life-threatening arrhythmias
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive stereotactic body radiation therapy (SBRT) or salvage radiation therapy (sXRT), combined with androgen receptor pathway inhibitors and androgen deprivation therapy depending on their assigned group. Treatment cycles repeat every 4 months (16 weeks) for up to 6 months in the absence of disease progression or unacceptable toxicity.
Visits every 4 months during treatment cycles
Duration - Until disease progression or end of study
After treatment, participants undergo watchful waiting or initial observation, with monitoring for disease progression. This includes ongoing blood sample collection and imaging using PET, CT, MRI, or bone scans throughout the trial.
Visits every 4 months during watchful waiting or observation
Duration - Up to 5 years
Upon completion of study interventions, participants are followed up every 6 months for up to 5 years to monitor progression and survival outcomes.
Follow-up visits every 6 months
Trial Site Locations
Total: 3 locations
1
Mayo Clinic in Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
C
Cancer Center Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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