Understanding how ADT for prostate cancer may raise blood pressure and whether nerves or kidneys are involved

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional study investigates the mechanisms behind hypertension in men treated with ADT for prostate cancer. It examines autonomic and renal factors to see how they may contribute to blood pressure changes. Participants may receive a GnRH agonist, an androgen receptor inhibitor, or placebo to understand the therapies' roles in blood pressure control. The study uses clinical assessments and controlled exercise testing to explore cardiovascular function and safety. Results could guide preventive strategies to reduce heart disease risk in this population.

Why it matters

Who can join: the full rules

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 it's running

• Virginia Commonwealth University
  Richmond, Virginia, United States Recruiting

Study contacts

• Principal investigator: Matthew Babcock, PhD — Virginia Commonwealth University
• Study coordinator: Matthew Babcock, PhD
• Email: babcockmc@vcu.edu
• Phone: ‪(804) 396-4718‬

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.