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

Sponsor: Virginia Commonwealth University

Sponsor score: 0

ClinicalTrials ID:NCT07848828

Provider View

This study aims to understand how androgen deprivation therapy (ADT), a common treatment for prostate cancer, affects blood pressure and heart health in men. Researchers are investigating whether changes in the nervous system or kidneys contribute to high blood pressure in men undergoing ADT.

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. ADT is a primary treatment for prostate cancer, which is the most common cancer in men after skin cancer. However, ADT can increase the risk of heart problems, including high blood pressure. This study will examine if issues with the nervous system or kidneys occur in men receiving ADT, as these systems are important in controlling blood pressure. The findings will help us understand how ADT contributes to heart disease and aid in developing ways 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.
  • Recently diagnosed with non-metastatic prostate cancer and planning to start ADT, or healthy individuals with PSA 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, such as blood pressure or cholesterol medications.
  • Willing to take specific prostate cancer medications (GnRH agonist and AR inhibitor).
  • Not taking antioxidant vitamins, corticosteroids, or anti-inflammatory medications, or willing to stop for four weeks before the study.
  • Not using external sex hormones for at least one year.

Exclusion Criteria

  • Active liver disease.
  • Chronic kidney disease or high levels of 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 outside the normal range, unless treated and re-evaluated.
  • Tobacco use within the last 12 months.

Locations

FACILITYZIPCITYSTATE
Virginia Commonwealth University23220RichmondVirginia

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