Contributions to Hypertension With Androgen Deprivation Therapy (ARCH)
Androgen Deprivation Therapy, Prostate Cancer, Hypertension
About this trial
This is an interventional other trial for Androgen Deprivation Therapy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
Prostate Cancer
Healthy + ADT
Healthy + Placebo
Men undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer
Healthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks
Healthy men undergoing placebo for 9 weeks.