Autonomic and Renal Contributions to Hypertension With ADT

Part of paid clinical trials in Richmond, Virginia.

Sponsor: Virginia Commonwealth University
Study ID: NCT07848828
Phase: PHASE4
Status: Recruiting

Apply to this trial

Conditions

Androgen Deprivation Therapy
Autonomic Dysfunction
Hypertension
Prostate Cancer
Renal Disease

Eligibility Criteria

Sex: MALE
Age: 40 Years - N/A
Healthy Volunteers: Accepted

Interventions

Gonadotropin Releasing Hormone Agonists (GNRH) — DRUG
8 weeks of GnRH agonist
Androgen receptor (AR) inhibitor — DRUG
2 weeks of AR inhibitor
Placebo — DRUG
Placebo tablet and injection

Study Details

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.

Key Dates

First listed: Sep 30, 2026
Start date: Aug 1, 2026
Status verified: Sep 2026
Primary completion: Jul 31, 2028
Completion: Jul 31, 2030

Study Design

Enrollment: 50 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Arms

Active Comparator: Prostate Cancer
Men undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer
Active Comparator: Healthy + ADT
Healthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks
Placebo Comparator: Healthy + Placebo
Healthy men undergoing placebo for 9 weeks.