Actively Recruiting

Phase 2
Age: 18Years +
MALE
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

Led by Mayo Clinic · Updated on 2026-04-20

532

Participants Needed

3

Research Sites

351 weeks

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

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.

CONDITIONS

Official 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

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Clinical confirmation of metastatic recurrent hormone-sensitive prostate cancer (DEVIATE groups A and B)
  • Five or fewer metastases with at least one outside the pelvis on advanced or conventional imaging (DEVIATE groups A and B)
  • Serum testosterone greater than 100 ng/dL (DEVIATE groups A and B)
  • Prostate-specific antigen (PSA) between 0.2 and 1.5 ng/mL with at least two consecutive measurements above 0.2 at least 5 days apart (BRIO groups C and D)
  • No local or metastatic recurrence on advanced molecular imaging (BRIO groups C and D)
  • Serum testosterone greater than 100 ng/dL (BRIO groups C and D)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Hemoglobin 8.0 g/dL or higher within 15 days prior to registration
  • Absolute neutrophil count 1500/mm3 or higher within 15 days prior to registration
  • Platelet count 80,000/mm3 or higher within 15 days prior to registration
  • Alanine aminotransferase (ALT) and aspartate transaminase (AST) up to 3 times the upper limit of normal (ULN), or up to 5 times ULN for patients with liver involvement, within 15 days prior to registration
  • Calculated creatinine clearance 30 ml/min or higher within 15 days prior to registration
  • Ability to provide written informed consent
  • Ability to complete questionnaires independently or with help
  • Willingness to provide blood and tissue samples for research
  • Willingness to return to the study site for follow-up during active monitoring
Not Eligible

You will not qualify if you...

  • Pregnant or nursing persons
  • Persons of childbearing potential or able to father a child who do not agree to use adequate contraception
  • Prior metastasis-directed therapy
  • Surgery within 3 weeks before registration
  • Prior chemotherapy for prostate cancer at any time
  • Use of androgen receptor pathway inhibitors such as abiraterone, apalutamide, darolutamide, or enzalutamide within the last 2 years
  • Uncontrolled infections or active illness
  • Psychiatric or social issues limiting study compliance
  • Dyspnea at rest requiring continuous oxygen therapy
  • Receiving other investigational agents for prostate cancer
  • Failure to recover from prior therapy effects except stable grade 1 peripheral neuropathy for at least 3 months
  • Severe concurrent diseases interfering with safety assessment
  • Symptomatic congestive heart failure or unstable heart conditions
  • Other active cancers within 3 years except treated non-melanoma skin cancer or papillary thyroid cancer
  • History of myocardial infarction within 6 months or ongoing life-threatening heart arrhythmias requiring maintenance therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

C

Clinical Trials Referral Office

CONTACT

C

Cancer Center Clinical Trials

CONTACT

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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