Study on How Androgen Deprivation Therapy Affects Blood Pressure in Men with Prostate Cancer

Sponsor: University of Colorado, Denver

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05700903

Provider View

This study aims to understand how androgen deprivation therapy (ADT), a common treatment for prostate cancer, may contribute to high blood pressure and heart disease in men. Researchers will investigate if changes in the nervous system or kidneys occur during ADT, which could affect blood pressure control.

Patient Parameters

Program Overview

The purpose of this study is to explore how androgen deprivation therapy (ADT), used to treat prostate cancer, might lead to high blood pressure and heart disease in men. Prostate cancer is a common cancer in men, and ADT is a primary treatment method. However, ADT can increase the risk of heart problems, including high blood pressure. This study will examine whether the nervous system or kidneys, which are important for controlling blood pressure, are affected in men undergoing ADT. The findings will help us understand how ADT contributes to heart disease and guide the development of treatments to prevent heart issues in prostate cancer survivors.

Eligibility Criteria

Inclusion Criteria

  • Men aged 40 years or older.
  • Resting blood pressure below 140/90 mmHg.
  • Fasting blood glucose level below 126 mg/dL.
  • Testosterone level of 400 ng/dL or higher.
  • Sedentary to recreationally active lifestyle.
  • Non-smokers.
  • Generally healthy based on medical history, physical exam, and tests, or recently diagnosed with non-metastatic prostate cancer planning to start ADT.
  • PSA level below 4.00 ng/dL if not in the cancer group.
  • Gleason Score of 7 or lower if in the prostate cancer group.
  • Not using medications that affect heart function, like blood pressure or cholesterol drugs.
  • Willing to take specific prostate cancer medications (GnRH agonist and AR inhibitor).
  • Not taking antioxidant vitamins, corticosteroids, or anti-inflammatory drugs, or willing to stop for four weeks before the study.
  • Not using external sex hormones for at least one year.

Exclusion Criteria

  • Acute liver disease.
  • Chronic kidney disease, high serum creatinine, or significant protein in urine.
  • Existing or active heart, kidney, or liver disease, epilepsy, or other seizure disorders.
  • Diabetes, active or chronic infections, or diseases affecting the nervous system.
  • Gleason Score of 8 or higher.
  • Thyroid problems, with specific TSH levels, unless treated and re-evaluated.
  • Tobacco use in the past 12 months.

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