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Taking people in United StatesPhase 4

Nerve and Kidney Roles in High Blood Pressure During Prostate Cancer Hormone Therapy

Studies how nerves and kidneys affect blood pressure in men on androgen deprivation therapy.

Key facts

Who runs it
Virginia Commonwealth University
Where
Richmond, United StatesSee the site
Trial code
Registry title
Autonomic and Renal Contributions to Hypertension With ADT
Status
Recruiting
Phase
Phase 4
People taking part
60 people, planned
Started
1 Aug 2026
Expected to end
Jul 2030
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Gonadotropin Releasing Hormone Agonists (GNRH)
  • Androgen receptor (AR) inhibitor
  • Placebo
Record updated
2 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men aged 40 or older who are either healthy or recently diagnosed with prostate cancer that has not spread and who plan to have androgen deprivation therapy.

Age
40 years or older
Sex
Men only
Disease stage
Healthy men, or men with a recent diagnosis of non-metastatic prostate cancer and a Gleason Score of 7 or lower who plan androgen deprivation therapy. Healthy men need a PSA below 4.00 ng/dL.
Earlier treatment
No medicines that affect the heart and blood vessels, such as blood pressure or cholesterol medicines. No antioxidant vitamins, corticosteroids or anti-inflammatory medicines, or willing to stop them for four weeks before the study. No sex hormones for at least one year.
Biomarker or test result
Resting blood pressure below 140/90 mmHg, fasted blood glucose below 126 mg/dL (7 mmol/L), and testosterone of 400 ng/dL or higher.

Main reasons for not taking part

  • Kidney disease, serum creatinine above 1.3 mg/dL (115 µmol/L), or a lot of protein in the urine (above 300 mg/g)
  • Heart, kidney or liver disease, epilepsy or other seizure disorder
  • Diabetes, ongoing infection, or a disease that affects the nervous system
  • Gleason Score of 8 or higher
  • Tobacco use within the previous 12 months

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • tobacco use within the previous 12 months
  • -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
  • chronic kidney disease, serum creatinine >1.3 mg/dL, macroalbuminuria >300 mg/g of proteinuria
  • 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

Where in United States

  • Virginia Commonwealth UniversityRichmond, United StatesContact: Matthew Babcock, PhDTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Prostate CancerExisting treatment, for comparison

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

    Treatment: Gonadotropin Releasing Hormone Agonists (GNRH) and Androgen receptor (AR) inhibitor

  • Healthy + ADTExisting treatment, for comparison

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

    Treatment: Gonadotropin Releasing Hormone Agonists (GNRH) and Androgen receptor (AR) inhibitor

  • Healthy + PlaceboPlacebo, for comparison

    Healthy men undergoing placebo for 9 weeks.

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Autonomic and Renal Contributions to Hypertension With Androgen Deprivation Therapy
Plain-language title
Nerve and Kidney Roles in High Blood Pressure During Prostate Cancer Hormone TherapyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
2 November 2026