Study on the Effects of Relugolix vs Leuprolide on Heart Health in Prostate Cancer Patients

Sponsor: Ohio State University Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06330805

Provider View

This clinical trial is comparing two treatments, relugolix and leuprolide, to see how they affect heart health in men with prostate cancer. Both treatments lower testosterone, which is important for treating prostate cancer, but may impact heart health differently.

Patient Parameters

Program Overview

This study is looking at how two different treatments for prostate cancer, relugolix and leuprolide, affect heart health and overall well-being. Both treatments work by lowering testosterone levels, which is a common approach for treating advanced prostate cancer. However, there is a concern that these treatments might affect heart health. The study aims to find out if relugolix might be safer for the heart compared to leuprolide. Participants will receive radiation therapy and one of the two treatments for six months. They will also undergo heart and exercise tests, complete quality-of-life surveys, and provide blood samples to monitor changes in their health.

Description

The main goal of this study is to see how relugolix and leuprolide, two treatments for prostate cancer, affect heart and lung function when combined with radiation therapy. Researchers will use various tests, including heart imaging and exercise tests, to measure heart performance and oxygen use. They will also look at how these treatments impact quality of life, strength, and body composition.

Participants will be randomly assigned to one of two groups. One group will receive leuprolide injections every three months, while the other group will take relugolix pills daily. Both groups will also receive radiation therapy. Throughout the study, participants will have heart tests, provide blood and urine samples, and complete surveys about their quality of life.

After finishing the treatment, participants will have follow-up visits at 1, 3, and 6 months to monitor their recovery and any changes in their health.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer within the last 270 days.
  • Have intermediate-risk prostate cancer with specific characteristics, such as certain PSA levels or Gleason scores.
  • No signs of cancer spreading to bones or lymph nodes based on recent imaging tests.
  • Aged 18 or older.
  • Good overall health with a performance status of 0 or 1.
  • Normal testosterone levels.
  • Adequate blood cell counts and organ function based on recent tests.
  • HIV-positive patients can participate if their viral load is undetectable.
  • Patients with hepatitis B or C can participate if their viral load is undetectable.
  • Must provide informed consent to participate in the study.

Exclusion Criteria

  • Previous prostate surgery or treatments aimed at curing prostate cancer.
  • Evidence of cancer spreading beyond the prostate.
  • History of other cancers unless disease-free for at least 3 years.
  • Previous radiation therapy to the prostate or pelvic area.
  • Previous hormonal treatments for prostate cancer.
  • Severe heart conditions or other serious health issues.
  • Significant urinary symptoms or disabilities affecting exercise tests.
  • Unable to undergo MRI scans or allergic to MRI contrast agents.
  • Active gastrointestinal or metabolic diseases.
  • Unable to swallow pills.
  • High-risk prostate cancer features, such as very high PSA levels or advanced tumor stage.

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