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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 belowSelect...
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.
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I am not taking any heart-related medications.
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I am healthy or have early-stage prostate cancer and plan to start hormone therapy.
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I am 40 years old or older.
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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
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 moreSecondary study objectives
Change in Sympathetic reactivity
Change in glomerular filtration rate
Change in renal plasma flow
+1 moreOther 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.
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.
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,810 Previous Clinical Trials
2,919,936 Total Patients Enrolled
Matthew Babcock, PhDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus