Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05700903 | Recruiting | Androgen Deprivation Therapy

Contributions to Hypertension With Androgen Deprivation Therapy
Sponsor:

University of Colorado, Denver

Brief 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.

Condition or disease

Androgen Deprivation Therapy

Prostate Cancer

Hypertension

Autonomic Dysfunction

Renal Disease

Intervention/treatment

Gonadotropin-Releasing Hormone Agonist

Androgen receptor inhibitor

Placebo

Phase

Phase 4

Study Type : Interventional
Estimated Enrollment : 228 participants
Masking : Triple
Primary Purpose : Other
Official Title : Autonomic and Renal Contributions to Hypertension With Androgen Deprivation Therapy
Actual Study Start Date : September 20, 2023
Estimated Primary Completion Date : March 31, 2028
Estimated Study Completion Date : March 31, 2028
Arm Intervention/treatment

Active Comparator: Prostate Cancer

Men undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer

Drug: Gonadotropin-Releasing Hormone Agonist

Active Comparator: Healthy + ADT

Healthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks

Drug: Androgen receptor inhibitor

Placebo Comparator: Healthy + Placebo

Healthy men undergoing placebo for 9 weeks.

Drug: Gonadotropin-Releasing Hormone Agonist
Ages Eligible for Study: 40 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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 chemistries and resting and exercise ECG during a physician supervised graded exercise treadmill test OR recent diagnosis of non-metastatic prostate cancer with plans to undergo androgen 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 Criteria
  • -acute liver disease;
  • chronic kidney disease, serum creatinine >1.3 mg/dL, macroalbuminuria >300 mg/g of proteinuria
  • pre-existing or active cardiac, renal or hepatic disease, epilepsy or other seizure disorder;
  • 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, volunteers with abnormal TSH values will be re-considered for participation after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement;
  • tobacco use within the previous 12 months
Contributions to Hypertension With Androgen Deprivation Therapy

Location Details

Please Choose a site

Contributions to Hypertension With Androgen Deprivation Therapy

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, Colorado

UCHealth University of Colorado Hospital

Aurora, Colorado, United States, 80045