Study Comparing Relugolix and Abiraterone Acetate to Leuprolide and Abiraterone Acetate for Heart Health in Prostate Cancer Patients

Sponsor: Emory University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06650579

Provider View

This clinical trial is examining the effects of two different hormone therapy combinations on heart health in men with advanced prostate cancer who are receiving radiation therapy. The study aims to determine which combination is safer for the heart while effectively treating cancer.

Patient Parameters

Program Overview

This study is exploring how two different hormone therapy combinations affect the heart in men with advanced prostate cancer who are also receiving radiation therapy. The trial compares the effects of leuprolide plus abiraterone acetate (AA) with relugolix plus AA. Both treatments aim to lower testosterone levels, which can help slow the growth of prostate cancer. However, hormone therapy can also impact heart health. By using advanced heart imaging and blood tests, researchers hope to identify which treatment combination poses less risk to the heart.

Description

The main goal of this study is to compare the heart health outcomes of two hormone therapy combinations in men with advanced prostate cancer who are receiving radiation therapy. One group will receive leuprolide and abiraterone acetate (AA), while the other group will receive relugolix and AA. Both groups will also receive radiation therapy.

Researchers will use heart imaging and blood tests to monitor the effects of these treatments on the heart. They will also look for genetic factors that might make some patients more prone to heart issues from these treatments.

Participants will be randomly assigned to one of two groups:

  • Group 1: Will receive leuprolide injections every 3 to 6 months, along with daily oral AA and prednisone for up to 24 months, unless the cancer progresses or side effects become too severe. Radiation therapy will also be given. Some patients may receive an additional medication, bicalutamide, for a short period at the start of treatment. Heart imaging and blood tests will be done before treatment and after 12 months.

  • Group 2: Will take daily oral relugolix, along with daily oral AA and prednisone for up to 24 months, unless the cancer progresses or side effects become too severe. Radiation therapy will also be given. Heart imaging and blood tests will be done before treatment and after 12 months.

After finishing the treatment, participants will have follow-up visits at 30 and 60 days to check testosterone levels.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older
  • Have non-metastatic prostate cancer
  • Have non-metastatic prostate cancer that has returned after initial treatment
  • Plan to receive radiation therapy aimed at curing the cancer
  • Plan to undergo up to 24 months of hormone therapy with AA and prednisone

Exclusion Criteria

  • Have prostate cancer that has spread and requires long-term hormone therapy or chemotherapy
  • Have previously received hormone therapy
  • Have previously received chemotherapy, immunotherapy, or radiation therapy
  • Have a history of heart surgery or procedures like bypass surgery or stent placement
  • Have a heart pacemaker or defibrillator

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.