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

Launched by MAYO CLINIC · Apr 16, 2024

Keywords

ClinConnect Summary

The DIVINE Trial is studying a combination of treatments for men with a type of advanced prostate cancer that is hormone-sensitive and has come back after previous treatment. Specifically, the trial looks at using a targeted radiation therapy called stereotactic body radiation therapy (SBRT) alongside medications that block the effects of male hormones (androgens) and lower the body’s production of these hormones. This approach aims to see if combining these treatments can be more effective than using SBRT alone.

To participate in the trial, men must be at least 18 years old and have confirmed metastatic prostate cancer that is hormone-sensitive. They should have five or fewer areas where the cancer has spread and be in reasonable health. Participants can expect to receive the treatments over several days and will be closely monitored throughout the study. It’s important to know that this trial is currently recruiting patients, and those interested must meet specific health criteria and be willing to follow the study's requirements, including providing blood and tissue samples for research.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• * 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
• • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
• • Hemoglobin ≥ 8.0 g/dL (obtained ≤ 15 days prior to registration)
• • Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 15 days prior to registration)
• • Platelet count ≥ 80,000/mm\^3 (obtained ≤ 15 days prior to registration)
• • 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)
• • Calculated creatinine clearance ≥ 30 ml/min using the Cockcroft-Gault formula (obtained ≤ 15 days prior to registration)
• • Provide written informed consent
• • Ability to complete questionnaire(s) by themselves or with assistance
• • Willingness to provide mandatory blood specimens for correlative research
• • Willingness to provide tissue specimens for correlative research
• • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
• Exclusion Criteria:
• • 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 contraception
• • Prior metastasis-directed therapy
• * 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 years
• * 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 requirements
• • Receiving any other investigational agent which would be considered as a treatment for prostate cancer.
• • 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
• • 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
• * 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 requirements
• • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
• • 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 cancer
• • History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias