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COMPLETEDPHASE4

Contributions to Hypertension With Androgen Deprivation Therapy

Autonomic and Renal Contributions to Hypertension With Androgen Deprivation Therapy

NCT05700903•University of Colorado, Denver

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

Age

40 - No limit years

Sex

MALE

Healthy Volunteers

Yes

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);
+3 more criteria

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

Locations (1)

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Key Dates

Start Date

September 20, 2023

Primary Completion Date

July 16, 2025

Completion Date

July 16, 2025

Last Updated

March 2, 2026

Enrollment

ACTUAL participants

Conditions

Androgen Deprivation TherapyProstate CancerHypertensionAutonomic DysfunctionRenal Disease

Interventions

Gonadotropin Releasing Hormone Agonists (GNRH)

DRUG

Androgen receptor (AR) inhibitor

DRUG

Placebo

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Contributions to Hypertension With Androgen Deprivation Therapy

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Natural History of Noncirrhotic Portal Hypertension

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer