Study Comparing Heart Effects of Relugolix and Leuprolide in Prostate Cancer Treatment

Sponsor: Emory University

Sponsor score: 40

ClinicalTrials ID:NCT05320406

This clinical trial is examining how two prostate cancer treatments, relugolix and leuprolide, affect the heart in men with localized prostate cancer receiving radiation therapy. The study aims to understand the heart-related side effects of these treatments and find ways to predict who might be at risk.

Patient Parameters

Program Overview

This study is looking at how prostate cancer treatments, specifically hormone therapies called androgen deprivation therapy (ADT), affect the heart in men with localized prostate cancer who are also receiving radiation therapy. There are concerns that some hormone therapies, like leuprolide, might harm the heart. A newer drug, relugolix, might be safer for the heart. The trial will explore how these treatments impact heart health and aim to find markers that can predict heart-related side effects.

Description

The main goals of this study are to:

  1. Compare how the hormone therapies leuprolide and relugolix affect heart health, specifically looking at heart artery health in men with prostate cancer.
  2. Understand how these treatments influence the body's immune response, which can affect heart health.
  3. Investigate how existing genetic factors related to inflammation might affect heart health when using these treatments.
  4. Identify imaging markers that could indicate a higher risk of heart issues from these treatments.

Participants are divided into three groups:

  • Group I: Patients receive only radiation therapy as part of their standard treatment.
  • Group II: Patients receive radiation therapy and leuprolide injections every 3 or 6 months for 6 to 24 months, depending on their cancer risk.
  • Group III: Patients receive radiation therapy and take relugolix pills daily for 6 to 24 months, depending on their cancer risk.

The study will monitor patients for any disease progression or unacceptable side effects.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 years or older
  • Have localized prostate cancer that has not spread
  • Have prostate cancer that has returned but not spread
  • Plan to receive radiation therapy with or without hormone therapy

Exclusion Criteria

  • Prostate cancer that has spread and requires more than 24 months of hormone therapy
  • Previous hormone therapy for prostate cancer
  • Previous chemotherapy or immunotherapy
  • History of heart surgery or procedures like cardiac bypass or stent placement

Locations

FACILITYZIPCITYSTATE
Emory Proton Therapy Center30308AtlantaGeorgia
Emory University Hospital Midtown30308AtlantaGeorgia
Emory University/Winship Cancer Institute30322AtlantaGeorgia
Emory Saint Joseph's Hospital30342AtlantaGeorgia

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