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
- Diseases
- Prostate cancer, High blood pressure
- 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
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCHealth University of Colorado Hospital Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.