228 Participants Needed

Androgen Deprivation Therapy for High Blood Pressure in Prostate Cancer Patients

(ARCH Trial)

MB
Overseen ByMatthew Babcock, PhD
Age: 18+
Sex: Male
Trial Phase: Phase 4
Sponsor: University of Colorado, Denver
Must be taking: GnRH agonist, AR inhibitor
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications, such as antihypertensives, lipid-lowering medications, antioxidant vitamins, corticosteroids, and anti-inflammatory medications, for four weeks before the study starts.

Is androgen deprivation therapy (ADT) safe for humans?

Androgen deprivation therapy (ADT) for prostate cancer, which includes treatments like GnRH agonists and antagonists, has been associated with an increased risk of cardiovascular events. However, GnRH antagonists may have a lower risk of these events compared to GnRH agonists, making them potentially safer for patients with heart concerns.12345

How is the drug Androgen Deprivation Therapy (ADT) unique for treating high blood pressure in prostate cancer patients?

Androgen Deprivation Therapy (ADT) using GnRH antagonists like abarelix and degarelix is unique because it rapidly reduces testosterone levels without causing an initial surge, unlike GnRH agonists, which can temporarily increase testosterone and potentially worsen cancer activity. This rapid suppression may be beneficial for patients with cardiovascular concerns, as it avoids the initial testosterone flare associated with increased cardiovascular risk.23678

What data supports the effectiveness of the drug Androgen Deprivation Therapy (ADT) for high blood pressure in prostate cancer patients?

The research shows that drugs like goserelin and leuprolide, which are part of ADT, are effective in reducing testosterone levels in prostate cancer patients, which is crucial for managing the disease. However, there is no direct evidence in the provided research about their effectiveness specifically for high blood pressure.12369

Who Is on the Research Team?

MB

Matthew Babcock, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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 (β‰₯8), or thyroid dysfunction.

Inclusion Criteria

Your blood pressure should not be lower than 140/90 mmHg when measured at rest.
Your blood sugar level should be below 126 mg/dL after fasting.
My prostate cancer has a Gleason score of 7 or less.
See 10 more

Exclusion Criteria

I have a current liver condition.
I have kidney issues with high creatinine and protein in my urine.
I have diabetes, an ongoing infection, or a nervous system condition.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo androgen deprivation therapy or placebo for 9 weeks to study its effects on blood pressure and related physiological parameters

9 weeks
Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Androgen receptor inhibitor
  • Gonadotropin-Releasing Hormone Agonist
  • Placebo
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Active Control
Placebo Group
Group I: Prostate CancerActive Control2 Interventions
Group II: Healthy + ADTActive Control2 Interventions
Group III: Healthy + PlaceboPlacebo Group1 Intervention

Androgen receptor inhibitor is already approved in European Union, United States for the following indications:

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Approved in European Union as Androgen Deprivation Therapy for:
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Approved in United States as Androgen Deprivation Therapy for:
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Approved in European Union as Abiraterone for:
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Approved in United States as Abiraterone for:
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Approved in European Union as Enzalutamide for:
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Approved in United States as Enzalutamide for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

Published Research Related to This Trial

GnRH antagonists significantly reduce cardiovascular risk compared to LHRH agonists in patients undergoing androgen deprivation therapy for metastatic prostate cancer, with a hazard ratio of 0.597, indicating a 40% lower risk.
Patients with pre-existing cardiovascular conditions benefit even more, showing a 56% lower risk of cardiovascular events when treated with GnRH antagonists compared to LHRH agonists.
[Cardiovascular risk patients under androgen deprivation therapy: Lower risk with GnRH antagonists compared to LHRH agonists?].Merseburger, AS., Sedding, D., HΓΌter, K.[2018]
Goserelin, a type of gonadotropin-releasing hormone agonist (GnRH-A), is more effective than leuprolide in maintaining low testosterone levels and has the highest efficacy in suppressing prostate-specific antigen, which is crucial for monitoring prostate cancer progression.
In terms of survival rates, goserelin shows impressive outcomes, with a 10-year overall survival rate of 87% when used as an adjuvant to radical prostatectomy, highlighting its effectiveness in advanced prostate cancer treatment.
Gonadotropin-releasing hormone agonists in prostate cancer: A comparative review of efficacy and safety.Raja, T., Sud, R., Addla, S., et al.[2022]
Gonadotropin-releasing hormone (GnRH) agonists, including leuprolide, goserelin, triptorelin, and histrelin, are effective for androgen suppression in men with advanced prostate cancer.
Preliminary data suggests that triptorelin may be more effective than leuprolide in maintaining low testosterone levels, although further studies are needed to confirm the clinical importance of this finding.
Comparison of single-agent androgen suppression for advanced prostate cancer.Lepor, H.[2022]

Citations

[Cardiovascular risk patients under androgen deprivation therapy: Lower risk with GnRH antagonists compared to LHRH agonists?]. [2018]
Gonadotropin-releasing hormone agonists in prostate cancer: A comparative review of efficacy and safety. [2022]
Comparison of single-agent androgen suppression for advanced prostate cancer. [2022]
Cardiovascular Safety of Degarelix Versus Leuprolide for Advanced Prostate Cancer: The PRONOUNCE Trial Study Design. [2022]
Abarelix and other gonadotrophin-releasing hormone antagonists in prostate cancer. [2013]
Gonadotropin-releasing hormone antagonist in the management of prostate cancer. [2020]
[Cardiovascular risk of androgen deprivation therapy for treatment of hormone-dependent prostate cancer : Differences between GnRH antagonists and GnRH agonists]. [2018]
Comparison of Surgical or Medical Castration-Related Cardiotoxicity in Patients with Prostate Cancer. [2022]
Cardiovascular Toxicity of Androgen Deprivation Therapy. [2021]
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