Contributions to Hypertension With Androgen Deprivation Therapy

Phase

Condition

Renal Failure

Autonomic Nervous System

Circulation Disorders

Treatment

Gonadotropin-Releasing Hormone Agonist

Androgen receptor (AR) inhibitor

Androgen receptor inhibitor

Clinical Study ID

NCT05700903

22-2201.cc

Ages > 40
Male
Accepts Healthy Volunteers

Study Summary

This study plans to learn more about contributors to high blood pressure in men who undergo androgen deprivation therapy (ADT) to treat prostate cancer. Prostate cancer is the most common non-skin cancer in men, affecting approximately 1 in 8 American men and its primary treatment is through the use of ADT. However, ADT increases the likelihood of developing heart disease including high blood pressure. This study will determine if dysfunction of the nervous system and/or kidneys occurs in men undergoing ADT, as these systems play a significant role in control of blood pressure. The results from this study will help us understand the ways in which ADT contributes to heart disease and help us develop therapies to prevent heart disease in prostate cancer survivors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

-age 40+ years;
resting blood pressure <140/90 mmHg;
fasted blood glucose <126 mg/dL;
testosterone ≥400 ng/dL;
sedentary to recreationally active;
nonsmokers;
healthy as determined by medical history, physical exam, blood and urine chemistriesand resting and exercise ECG during a physician supervised graded exercise treadmilltest OR recent diagnosis of non-metastatic prostate cancer with plans to undergoandrogen deprivation therapy;
PSA <4.00 ng/dL if in the non-cancer group;
Gleason Score ≤7 if in the prostate cancer group;
no use of medications that might influence cardiovascular function (e.g.,antihypertensives, lipid-lowering medications);
willing and able to be on GnRHagonist and AR inhibitor;
not taking antioxidant vitamins, corticosteroids, or anti-inflammatory medications,or willing to stop use for four weeks prior to the start of the study;
not using exogenous sex hormones for at least one year

Exclusion

Exclusion Criteria:

-acute liver disease;
chronic kidney disease, serum creatinine >1.3 mg/dL, macroalbuminuria >300 mg/g ofproteinuria
pre-existing or active cardiac, renal or hepatic disease, epilepsy or other seizuredisorder;
diabetes, active or chronic infection, disease that affects the nervous system;
Gleason Score ≥8;
thyroid dysfunction, defined as ultrasensitive TSH <0.5 or >5.0 mU/L, volunteerswith abnormal TSH values will be re-considered for participation after follow-upevaluation by the PCP with initiation or adjustment of thyroid hormone replacement;
tobacco use within the previous 12 months

Study Design