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

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.

Conditions

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

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Mayo Clinic

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-03

Primary Completion

2031-02-28

Completion

2031-02-28

FDA Drug

Yes

Countries

• United States

Study Locations