Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial

  • Recruiting
  • Treatment
  • Interventional
  • Randomized
  • Drug & Other
  • PHASE2
  • Mayo Clinic
  • 18 Years -


Study Purpose

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 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. Giving SBRT alone with watchful waiting may be as effective in treating prostate cancer as giving SBRT together with ARPI and ADT.

Intervention

Procedure : Positron Emission Tomography

Drug : Prednisone

Other : Patient Observation

Drug : Abiraterone

Drug : Apalutamide

Procedure : Biospecimen Collection

Procedure : Bone Scan

Procedure : Computed Tomography

Drug : Darolutamide

Drug : Degarelix

Drug : Enzalutamide

Drug : Goserelin

Drug : Histrelin

Drug : Leuprolide

Procedure : Magnetic Resonance Imaging

Other : Questionnaire Administration

Drug : Relugolix

Radiation : Stereotactic Body Radiation Therapy

Drug : Triptorelin


Eligibility Requirements

info icon Age ≥ 18 years

info icon The following disease characteristics: * 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

info icon Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2

info icon Hemoglobin ≥ 8.0 g/dL (obtained ≤ 15 days prior to registration)

info icon Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 15 days prior to registration)

info icon Platelet count ≥ 80,000/mm\^3 (obtained ≤ 15 days prior to registration)

info icon Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x upper limit of normal (ULN) ( ≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)

info icon Calculated creatinine clearance ≥ 30 ml/min using the Cockcroft-Gault formula (obtained ≤ 15 days prior to registration)

info icon Provide written informed consent

info icon Ability to complete questionnaire(s) by themselves or with assistance

info icon Willingness to provide mandatory blood specimens for correlative research

info icon Willingness to provide tissue specimens for correlative research

info icon Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

info icon 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 contraceptio

info icon Prior metastasis-directed therapy

info icon Any of the following prior therapies: * Surgery ≤ 3 weeks prior to registration * Chemotherapy for prostate cancer at any time * Androgen receptor pathway inhibitor such as abiraterone, apalutamide, darolutamide, or enzalutamide in the last 2 year

info icon 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 requirement

info icon Receiving any other investigational agent which would be considered as a treatment for prostate cancer.

info icon 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

info icon 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

info icon 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 requirement

info icon Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm

info icon Other active malignancy ≤ 3 years prior to registration * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix * 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 cance

info icon History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

Recruiting status

Recruiting

Estimated enrollment

120

 
Study start date

Jun 03, 2024

Study end date

May 31, 2029

Last updated

Mar 23, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Drug & Other

Study phase

PHASE2

Allocation

Randomized

 

Sponsor:

Mayo Clinic

Collaborator:

N/A

Investigator:

Jacob J. Orme, MD, PhD

NCT06378866

Clinic Location Investigator Distance RECRUITING STATUS Contact