Androgen Deprivation Therapy for High Blood Pressure in Prostate Cancer

(ARCH Trial)

This trial investigates why some men develop high blood pressure during androgen deprivation therapy (ADT) for prostate cancer. Researchers aim to determine if changes in the nervous system or kidneys contribute to this issue. Participants will be divided into groups: some will receive ADT, including treatments like androgen receptor inhibitors and gonadotropin-releasing hormone agonists, while others will receive a placebo for comparison. Men with prostate cancer or those who are healthy but meet specific criteria, such as not smoking and not using certain medications, qualify for this study. The goal is to find ways to prevent heart disease in prostate cancer survivors. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand how it benefits more patients.

Research has shown that androgen deprivation therapy (ADT), which includes drugs that block male hormones and those that lower hormone levels, is generally well-tolerated. ADT is a common treatment for prostate cancer and has FDA approval, indicating a known safety record.

Researchers are excited about the treatments using androgen receptor inhibitors and gonadotropin-releasing hormone agonists because they offer a unique approach to managing high blood pressure in men with prostate cancer. Unlike standard blood pressure medications that primarily target the cardiovascular system, these treatments work by suppressing hormones that can influence both prostate cancer progression and blood pressure regulation. This dual-action mechanism could provide a more comprehensive treatment strategy, potentially improving outcomes for prostate cancer patients who also struggle with high blood pressure. Additionally, researchers are exploring the impact of these hormonal therapies on healthy individuals to understand their full range of effects and optimize their use.

This trial will compare different approaches to androgen deprivation therapy (ADT) for prostate cancer. Studies have shown that ADT effectively treats prostate cancer by slowing cancer cell growth. ADT blocks male hormones, called androgens, from fueling the cancer. However, ADT can increase the risk of heart-related problems, such as high blood pressure and heart disease, especially when using certain medications called androgen receptor inhibitors. Research indicates that while another type of ADT medication, known as GnRH agonists, benefits prostate cancer treatment, they may also cause heart-related side effects. Patients must consider both the benefits and risks of ADT when making treatment decisions. Participants in this trial will receive either a combination of GnRH agonists and androgen receptor inhibitors or a placebo, allowing for a comparison of these treatment approaches.⁶⁷⁸⁹¹⁰