Recruiting

Androgen Deprivation Therapy

Sponsor:

Virginia Commonwealth University

Code:

NCT07848828

Conditions

Androgen Deprivation Therapy

Prostate Cancer

Hypertension

Autonomic Dysfunction

Renal Disease

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Accepted

Interventions

Gonadotropin Releasing Hormone Agonists (GNRH)

Androgen receptor (AR) inhibitor

Placebo

Study Details

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.

Conditions

Androgen Deprivation Therapy

Prostate Cancer

Hypertension

Autonomic Dysfunction

Renal Disease

Study ID

NCT07848828

Start date

Aug 1, 2026

Status verified date

Sep, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Gonadotropin Releasing Hormone Agonists (GNRH)

8 weeks of GnRH agonist

Androgen receptor (AR) inhibitor

2 weeks of AR inhibitor

Placebo

Placebo tablet and injection

Primary outcome measure

  • Change in cardiovagal baroreflex sensitivity [ Time Frame: Before and after 9 weeks of ADT or placebo ]
  • Change in blood pressure reactivity to the cold pressor test [ Time Frame: Before and after 9 weeks of androgen deprivation therapy or placebo ]
  • Change in exercise pressor reflex [ Time Frame: Before and after 9 weeks of androgen deprivation therapy or placebo ]
  • Change in ambulatory blood pressure variability [ Time Frame: Before and after 9 weeks of androgen deprivation therapy or placebo ]
  • Change in beat-to-beat blood pressure variability [ Time Frame: Before and after 9 weeks of androgen deprivation therapy or placebo ]
  • Change in renal vascular resistance [ Time Frame: Before and after 9 weeks of androgen deprivation therapy or placebo ]
  • Change in kidney injury biomarkers [ Time Frame: Before and after 9 weeks of androgen deprivation therapy or placebo ]

Central Contacts and Locations

Central contacts

Matthew Babcock, PhD

‪(804) 396-4718‬babcockmc@vcu.edu

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23220

Contacts

Matthew Babcock, PhD

‪(804) 396-4718‬babcockmc@vcu.edu

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-01. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.