What is the mechanism of action of this treatment?

The most common treatments for Autonomic Nervous System Disorders (ANSD) often involve medications that modulate neurotransmitter levels or receptor activity to restore autonomic balance. For instance, beta-blockers reduce sympathetic nervous system activity by blocking adrenergic receptors, while anticholinergics inhibit parasympathetic activity by blocking acetylcholine receptors. In the context of Androgen Deprivation Therapy (ADT), which reduces androgen levels to manage prostate cancer, the reduction in androgens can impact autonomic function by altering cardiovascular and metabolic regulation. Understanding these mechanisms is crucial for ANSD patients because it helps tailor treatments that mitigate autonomic imbalances exacerbated by hormonal therapies like ADT.

What side effects are associated with this type of intervention?

Common treatments for Autonomic Nervous System Disorders, particularly those involving reduction of androgen levels like Androgen Deprivation Therapy (ADT), often include medications that can lead to various side effects. ADT, used primarily in prostate cancer treatment, is known to increase the risk of cardiovascular issues such as high blood pressure and heart disease. Other side effects may include hot flashes, fatigue, decreased libido, and potential metabolic changes. Additionally, mild reversible elevations of hepatic transaminases have been observed in some patients. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

FDA-approved treatments for autonomic nervous system disorders include droxidopa, which is used for neurogenic orthostatic hypotension. This condition involves autonomic dysfunction similar to the cardiovascular issues seen in patients undergoing Androgen Deprivation Therapy (ADT) for prostate cancer. Droxidopa has shown positive results in improving symptoms like dizziness and fainting upon standing. Another treatment, prenalterol, has been used for orthostatic hypotension in Shy-Drager syndrome, although its use is less common. These treatments highlight the importance of managing autonomic dysfunction in conditions that affect blood pressure regulation.

What other types of research exist?

Promising alternatives to Androgen Deprivation Therapy (ADT) for patients with autonomic nervous system disorders include the use of GnRH antagonists like relugolix, which have shown a lower incidence of major cardiovascular events compared to GnRH agonists. Additionally, novel hormonal agents such as abiraterone and enzalutamide may be considered, although they also carry some cardiovascular risks. It is crucial to evaluate each patient's cardiovascular health and consult with a cardiologist to optimize care during treatment.

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Androgen Receptor Inhibitor

Androgen Deprivation Therapy for High Blood Pressure in Prostate Cancer Patients (ARCH Trial)

Phase 4

Recruiting

Led By Matthew Babcock, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Gleason Score ≤7 if in the prostate cancer group

PSA <4.00 ng/dL if in the non-cancer group

Must not have

Acute liver disease

Chronic kidney disease, serum creatinine >1.3 mg/dL, macroalbuminuria >300 mg/g of proteinuria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and after 9 weeks of androgen deprivation therapy or placebo

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial aims to understand why men with prostate cancer who are treated with ADT have a higher risk of heart disease. Researchers will look at whether ADT affects the nervous system or kidneys, which help control blood pressure. The goal is to find ways to prevent heart disease in these patients. Androgen deprivation therapy (ADT) has been used for prostate cancer treatment but is associated with increased cardiovascular risks.

Who is the study for?

This trial is for men aged 40+ with normal blood pressure and testosterone levels, who are either healthy or have non-metastatic prostate cancer planning to undergo ADT. Participants should not smoke, take certain medications, or have diabetes, severe kidney disease, heart conditions, nervous system diseases, high Gleason scores (≥8), or thyroid dysfunction.

What is being tested?

The study investigates how ADT for prostate cancer may lead to high blood pressure by affecting the nervous system and kidneys. It involves a Gonadotropin-Releasing Hormone Agonist and Androgen receptor inhibitor versus placebo in controlling blood pressure.

What are the potential side effects?

Potential side effects include changes in cardiovascular function due to hormonal alterations from the treatments. Specific side effects aren't listed but could relate to typical reactions from hormone therapies such as fatigue, hot flashes, mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My prostate cancer has a Gleason score of 7 or less.

Select...

My PSA level is below 4.00 ng/dL, and I am not diagnosed with cancer.

Select...

I haven't used hormone therapy for over a year.

Select...

I am not taking any heart-related medications.

Select...

I am healthy or have early-stage prostate cancer and plan to start hormone therapy.

Select...

I am 40 years old or older.

Select...

I am willing and able to take hormone therapy for my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a current liver condition.

Select...

I have kidney issues with high creatinine and protein in my urine.

Select...

My prostate cancer is aggressive (Gleason Score ≥8).

Select...

I do not have heart, kidney, liver diseases, epilepsy, or any seizure disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and after 9 weeks of androgen deprivation therapy or placebo

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and after 9 weeks of androgen deprivation therapy or placebo

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after 9 weeks of androgen deprivation therapy or placebo for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Cardiovagal Baroreflex Sensitivity

Change in Renal dysfunction biomarkers

Change in ambulatory blood pressure variability

+4 more

Secondary study objectives

Change in Sympathetic reactivity

Change in glomerular filtration rate

Change in renal plasma flow

+1 more

Other study objectives

Change in Body composition

Change in Inflammation

Change in Oxidative stress

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Prostate CancerActive Control2 Interventions

Men undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer

Group II: Healthy + ADTActive Control2 Interventions

Healthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks

Group III: Healthy + PlaceboPlacebo Group1 Intervention

Healthy men undergoing placebo for 9 weeks.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Autonomic Nervous System Disorders (ANSD) often involve medications that modulate neurotransmitter levels or receptor activity to restore autonomic balance. For instance, beta-blockers reduce sympathetic nervous system activity by blocking adrenergic receptors, while anticholinergics inhibit parasympathetic activity by blocking acetylcholine receptors. In the context of Androgen Deprivation Therapy (ADT), which reduces androgen levels to manage prostate cancer, the reduction in androgens can impact autonomic function by altering cardiovascular and metabolic regulation. Understanding these mechanisms is crucial for ANSD patients because it helps tailor treatments that mitigate autonomic imbalances exacerbated by hormonal therapies like ADT.