Study on Radiation Therapy Plus Hormone Treatments for Metastatic, Recurrent Hormone-Sensitive Prostate Cancer (DIVINE Trial)

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06378866

Provider View

This clinical trial is exploring the effects of combining radiation therapy with hormone treatments to manage prostate cancer that has spread and returned after initial improvement. The study aims to determine if this combination is as effective as radiation therapy alone.

Patient Parameters

Program Overview

This study is investigating how well a combination of stereotactic body radiation therapy (SBRT) and hormone treatments works for patients with prostate cancer that has spread to other parts of the body and has come back after treatment. SBRT is a precise form of radiation therapy that targets tumors while sparing healthy tissue. Hormone treatments include androgen deprivation therapy (ADT) and androgen receptor pathway inhibitors (ARPI), which help stop the growth of cancer cells by reducing or blocking male hormones. The study will compare the effectiveness of SBRT alone with SBRT combined with hormone treatments.

Description

The main goal of this study is to compare the time patients remain free from cancer progression when treated with SBRT and hormone therapy (ADT/ARPI) versus SBRT alone. Secondary goals include comparing overall survival, time to cancer returning locally or spreading further, and the safety of the hormone treatments. The study will also look at how long patients remain free from castration-resistant prostate cancer (CRPC), which is a form of prostate cancer that continues to grow despite low testosterone levels.

Participants will be randomly assigned to one of two groups:

  • Group A: Patients will receive SBRT along with hormone treatments (ARPI and ADT) for six months, followed by a period of watchful waiting until the cancer progresses.
  • Group B: Patients will receive SBRT followed by watchful waiting without additional hormone treatments.

Throughout the study, participants will have regular blood tests and imaging scans (such as PET, CT, MRI, or bone scans) to monitor their health and the cancer's response to treatment. After completing the study treatments, participants will have follow-up visits every six months for up to five years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of metastatic, recurrent hormone-sensitive prostate cancer.
  • Have five or fewer cancer spread sites, with at least one outside the pelvis.
  • Have a testosterone level greater than 100 ng/dL.
  • Be in good overall health with an ECOG performance status of 0, 1, or 2.
  • Have adequate blood counts and organ function based on recent tests.
  • Be able to provide informed consent and complete questionnaires.
  • Be willing to provide blood and tissue samples for research.
  • Be willing to return for follow-up visits during the study.

Exclusion Criteria

  • Pregnant or nursing individuals, or those who can have children but are not using contraception.
  • Have had previous treatments targeting cancer spread.
  • Have had recent surgery, chemotherapy, or certain hormone treatments for prostate cancer.
  • Have uncontrolled illnesses or conditions that could interfere with the study.
  • Be taking other investigational drugs for prostate cancer.
  • Have not recovered from side effects of previous treatments, except for stable mild nerve damage.
  • Have other serious health conditions that could affect participation.
  • Have had another active cancer within the last three years, except for certain skin or cervical cancers.
  • Have had a heart attack or severe heart failure within the last six months.

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