Contributions to Hypertension With Androgen Deprivation Therapy

NCT ID: NCT05700903

Last Updated: 2025-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-20
• Study Completion Date: 2025-07-16

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Prostate Cancer

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

Group Type: ACTIVE_COMPARATOR

Gonadotropin Releasing Hormone Agonists (GNRH)

Intervention Type: DRUG

8 weeks of GnRH agonist

Androgen receptor (AR) inhibitor

Intervention Type: DRUG

2 weeks of AR Inhibitor

Healthy + ADT

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

Group Type: ACTIVE_COMPARATOR

Gonadotropin Releasing Hormone Agonists (GNRH)

Intervention Type: DRUG

8 weeks of GnRH agonist

Androgen receptor (AR) inhibitor

Intervention Type: DRUG

2 weeks of AR Inhibitor

Healthy + Placebo

Healthy men undergoing placebo for 9 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet and injection

Interventions

Gonadotropin Releasing Hormone Agonists (GNRH)

8 weeks of GnRH agonist

Intervention Type: DRUG

Androgen receptor (AR) inhibitor

2 weeks of AR Inhibitor

Intervention Type: DRUG

Placebo

Placebo tablet and injection

Intervention Type: DRUG

Other Intervention Names

Leuprolide; Goserelin; Bicalutamide; Flutamide; Enzalutamide

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Babcock, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Countries

United States

Other Identifiers

22-2201.cc

Identifier Type: -

Identifier Source: org_study_id