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NCT05700903TerminatedPhase 4

Contributions to Hypertension With Androgen Deprivation Therapy

Autonomic and Renal Contributions to Hypertension With Androgen Deprivation Therapy

Source: ClinicalTrials.gov · Last updated 2 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
10 (actual)
First submitted
10 Jan 2023
Start date
20 Sept 2023
Primary completion date
16 Jul 2025
Lead sponsor
University of Colorado, Denver
NCT number
NCT05700903

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • tobacco use within the previous 12 months

Other illness

  • -acute liver disease;
  • 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;

Lab values

  • chronic kidney disease, serum creatinine >1.3 mg/dL, macroalbuminuria >300 mg/g of proteinuria

Other

  • 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;

Who the study is looking for

  • -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

Age in the registry: 40 years to - · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
UCHealth University of Colorado Hospital
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.