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Terminated

NCT Number: NCT05700903

Contributions to Hypertension With Androgen Deprivation Therapy

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.

Why the study stopped: Study completed
Terminated

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Key information

Conditions

Androgen Deprivation Therapy Autonomic Dysfunction Autonomic Nervous System Diseases Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hypertension Kidney Diseases Male Urogenital Diseases Neoplasms Neoplasms by Site Nervous System Diseases Primary Dysautonomias Prostate Cancer Prostatic Diseases Prostatic Neoplasms Renal Disease Urogenital Diseases Urogenital Neoplasms Urologic Diseases Vascular Diseases

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gonadotropin Releasing Hormone Agonists (GNRH)

Drug

8 weeks of GnRH agonist

Other names: Leuprolide, Goserelin

Androgen receptor (AR) inhibitor

Drug

2 weeks of AR Inhibitor

Other names: Bicalutamide, Flutamide, Enzalutamide

Placebo

Drug

Placebo tablet and injection

Primary outcomes

  1. Change in Cardiovagal Baroreflex Sensitivity

    Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo

    The change in cardiovagal baroreflex sensitivity will be assessed via the sequence method

  2. Change in Blood Pressure Reactivity to the Cold Pressor Test

    Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo

    The change in systolic blood pressure will be assessed from quiet rest to sympathetic activation using the cold pressor test

  3. Change in Exercise Pressor Reflex

    Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo

    The change in systolic blood pressure will be assessed from quiet rest to isometric handgrip exercise

  4. Change in Ambulatory Blood Pressure Variability

    Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo

    Ambulatory systolic blood pressure variability will be determined from 24-hour ambulatory blood pressure monitoring using the standard deviation of blood pressure readings

  5. Change in Beat-to-beat Blood Pressure Variability

    Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo

    Beat-to-beat systolic blood pressure variability will be determined using the standard deviation of blood pressure readings from finger photoplethysmography measured in the laboratory.

  6. Change in Renal Vascular Resistance

    Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo

    Renal blood flow will be determined using ultrasound and blood pressure will be determined using finger photoplethysmography. These measures will be used to estimate renal vascular resistance.

  7. Change in Renal Dysfunction Biomarkers

    Time frame: Before and after 9 weeks of androgen deprivation therapy or placebo

    Neutrophil gelatinase-associated lipocalin (NGAL), tissue inhibitor of metalloproteinases 2 (TIMP2), and insulin-like growth factor binding protein 7 (IGFBP7) will be quantified in urine using commercially available assay kits. Concentrations will be normalized to urinary flow rate.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Autonomic and Renal Contributions to Hypertension With Androgen Deprivation Therapy

Acronym: ARCH

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 26, 2023
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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