NCT07848828 · Virginia Commonwealth University
Autonomic and Renal Contributions to Hypertension With ADT
(ARCH)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Gonadotropin Releasing Hormone Agonists (GNRH)
8 weeks of GnRH agonist
DRUG
Androgen receptor (AR) inhibitor
2 weeks of AR inhibitor
DRUG
Placebo
Placebo tablet and injection
Primary outcome measures
Change in cardiovagal baroreflex sensitivity
Time frame: Before and after 9 weeks of ADT or placebo
The change in cardiovagal baroreflex sensitivity will be assessed via the sequence method
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
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
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
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.
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.
Change in kidney injury 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Richmond, Virginia
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 30, 2026 · Source of record for eligibility and locations