Understanding high blood pressure in men receiving hormone therapy for prostate cancer

Autonomic and Renal Contributions to Hypertension With Androgen Deprivation Therapy

This study is testing how hormone therapy for prostate cancer affects blood pressure in men and what factors might be causing any changes.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 228 (estimated)
• Ages: 40 Years and up
• Sex: Male
• Sponsor: University of Colorado, Denver (Academic / other)
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT05700903 on ClinicalTrials.gov

What this trial studies

This study aims to investigate the factors contributing to high blood pressure in men undergoing androgen deprivation therapy (ADT) for prostate cancer. It will assess the role of nervous system and kidney dysfunction in these patients, as both systems are crucial for blood pressure regulation. The study will involve administering Gonadotropin Releasing Hormone Agonists and androgen receptor inhibitors, alongside a placebo, to evaluate their effects on blood pressure and overall cardiovascular health. The findings could lead to better prevention strategies for heart disease in prostate cancer survivors.

Who should consider this trial

Good fit: Ideal candidates are men aged 40 and older who are healthy or have non-metastatic prostate cancer and are planning to undergo androgen deprivation therapy.

Not a fit: Patients with significant cardiovascular issues or those currently on medications affecting cardiovascular function may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help develop therapies to prevent heart disease in men treated for prostate cancer.

How similar studies have performed: While there is ongoing research into the cardiovascular effects of androgen deprivation therapy, this specific focus on hypertension and its contributors is relatively novel.

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

Where this trial is running

Aurora, Colorado

• UCHealth University of Colorado Hospital — Aurora, Colorado, United States (Recruiting)

Study contacts

• Principal investigator: Matthew Babcock, PhD — University of Colorado, Denver
• Study coordinator: Matthew Babcock, PhD

Conditions Androgen Deprivation Therapy; Prostate Cancer; Hypertension; Autonomic Dysfunction; Renal Disease