RecruitingPhase 2NCT06378866

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

MC230502 Dynamic Investigator Initiated Enterprise (DIVINE) in Prostate Cancer


Sponsor

Mayo Clinic

Enrollment

532 participants

Start Date

Jun 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (called DIVINE) is studying different strategies for men with prostate cancer that has either spread to a few spots (oligometastatic) after initial treatment, or shows early signs of rising PSA after surgery. It compares focused radiation to the cancer spots plus hormone-blocking therapy, given either immediately or delayed. **You may be eligible if...** - You are 18 or older - You have hormone-sensitive prostate cancer that has come back in 5 or fewer spots, at least one outside the pelvis (DEVIATE group); OR your PSA is rising after surgery but imaging shows no visible cancer (BRIO group) - Your testosterone level is above 100 ng/mL - You are in generally good physical health (ECOG 0-2) - Your blood counts are adequate **You may NOT be eligible if...** - You have cancer that cannot be treated with focused radiation - Your overall health is too poor for the planned treatments - You do not meet the specific PSA or imaging criteria for either group Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAbiraterone

Given abiraterone

DRUGApalutamide

Given apalutamide

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Scan

Undergo bone scan

PROCEDUREComputed Tomography

Undergo CT

DRUGDarolutamide

Given darolutamide

DRUGDegarelix

Given degarelix

DRUGEnzalutamide

Given enzalutamide

DRUGGoserelin

Given goserelin

DRUGHistrelin

Given histrelin

DRUGLeuprolide

Given leuprolide

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

OTHERPatient Observation

Undergo watchful waiting or initial observation

PROCEDUREPositron Emission Tomography

Undergo PET

DRUGPrednisone

Given prednisone

OTHERQuestionnaire Administration

Ancillary studies

DRUGRelugolix

Given relugolix

RADIATIONStereotactic Body Radiation Therapy

Undergo SBRT

DRUGTriptorelin

Given triptorelin

RADIATIONRadiation Therapy

Undergo sXRT

PROCEDUREImage-Guided Therapy

Undergo image-guided therapy


Locations(3)

Mayo Clinic in Arizona

Phoenix, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06378866


Related Trials