Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
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At a Glance
Age
40 and older
Sex
Male
Trial phase
Phase 4
Study type
Interventional
Purpose
Basic Science
Participants needed
50 (estimated)
Sponsor
Virginia Commonwealth University · Other
Who this trial is looking for
This trial is looking for men with prostate cancer who are 40 years or older and want to learn about how treatment might affect their blood pressure. Participants will undergo evaluation and monitoring related to their heart and kidney function while using androgen deprivation therapy for their cancer treatment.
Are You a Good Fit for This Trial?
Must not be takingCorticosteroidsAnti-inflammatory medicationsAntioxidant vitamins
You may be able to join if
I am 40 years or older
I have been diagnosed with prostate cancer
I will start androgen deprivation therapy
My blood pressure is less than 140/90 mmHg
My testosterone level is 400 ng/dL or higher
I do not smoke
I am healthy based on my medical history and physical exam
I have a Gleason Score of 7 or lower
You may not be able to join if
I have acute liver disease
I have chronic kidney disease
I have a history of heart, kidney, or liver disease
I have diabetes
I have had a seizure disorder
I have a Gleason Score of 8 or higher
I have thyroid dysfunction
I have used tobacco in the last 12 months
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 pres…
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.
Trial Locations
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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 exer…
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
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