DRUG
Gonadotropin Releasing Hormone Agonists (GNRH)
8 weeks of GnRH agonist
Contributions to Hypertension With Androgen Deprivation Therapy
Status
Completed
Phase
Phase 4
Enrollment
10
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Treatment arms and agents.
DRUG
Androgen receptor (AR) inhibitor
2 weeks of AR Inhibitor
DRUG
Placebo
Placebo tablet and injection
Timeline
From registration to results.
First posted
Jan 26, 2023
Study start
Sep 20, 2023
Primary completion
Jul 16, 2025
Study completion
Jul 16, 2025
Results posted
Not reported
Registry updated
Mar 2, 2026
Outcomes
What the study measures.
Primary outcomes
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 the modified Oxford procedure
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 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 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 blood pressure variability will be determined from 24-hour ambulatory blood pressure monitoring.
Change in beat-to-beat blood pressure variability
Time frame · Before and after 9 weeks of androgen deprivation therapy or placebo
Beat-to-beat blood pressure variability will be using 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 Renal dysfunction biomarkers
Time frame · Before and after 9 weeks of androgen deprivation therapy or placebo
Neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule (KIM)-1, interleukin (IL)-18, and vanin-1 will be quantified in urine using commercially available assay kits. Concentrations will be normalized to urinary flow rate.
Secondary outcomes
Change in sympathetic baroreflex sensitivity
Time frame · Before and after 9 weeks of androgen deprivation therapy or placebo
Changes in muscle sympathetic nerve activity in response to changes in blood pressure will be assessed using the modified Oxford procedure
Change in Sympathetic reactivity
Time frame · Before and after 9 weeks of androgen deprivation therapy or placebo
The change in muscle sympathetic nerve activity will be assessed from quiet rest to sympathetic activation using the cold pressor test.
Change in glomerular filtration rate
Time frame · Before and after 9 weeks of androgen deprivation therapy or placebo
Glomerular filtration rate and renal plasma flow will be calculated by iohexol (Omnipaque 300, GE Healthcare) clearance technique. Plasma and urine iohexol and p-aminohippurate clearance will be measured on a High-Performance Liquid Chromatography (HPLC, Waters, Milford, MA).
Change in renal plasma flow
Time frame · Before and after 9 weeks of androgen deprivation therapy or placebo
Renal plasma flow will be calculated by p-aminohippurate (Basic Pharma) clearance techniques. Plasma and urine p-aminohippurate clearance will be measured on a High-Performance Liquid Chromatography (HPLC, Waters, Milford, MA).
Eligibility
Who can take part.
- Minimum age
- 40 Years
- Maximum age
- Not reported
- 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); * 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
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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