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Androgen Receptor Inhibitor

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

Q: Are new participants currently being accepted for this experiment?

Consistent with clinicaltrials.gov, this particular investigation is still in the process of recruiting participants. The trial was initially announced on September 20th 2023 and has been recently revised as of November 14th 2023.

Q: How many individuals are taking part in this experiment?

Affirmative. According to the clinicaltrials.gov platform, this medical trial initiated on September 20th of this year is presently recruiting participants. A total of 228 patients must be sourced from a single site before the study can begin in earnest.

Q: What is the purpose of this research endeavor?

This medical trial aims to observe the effect of androgen deprivation therapy or placebo over a 9-week period on renal dysfunction biomarkers. The primary outcome will be tracked through changes in glomerular filtration rate, which is carried out using Omnipaque 300 (GE Healthcare) clearance technique. Additionally, sympathetic baroreflex sensitivity is evaluated with modified Oxford procedure while renal plasma flow uses p-aminohippurate (Basic Pharma) clearance techniques that are assessed via HPLC technology (Waters, Milford, MA).

Q: What levels of peril does Prostate Cancer pose for individuals?

Our experts at Power have assigned <a href="https://www.withpower.com/clinical-trials/prostate-cancer">Prostate cancer</a> a score of 3, demonstrating their confidence in its safety given it has reached Phase 4 of the clinical trial process and been approved.

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

ARCH Trial Summary

This trial looks at how prostate cancer treatment (ADT) affects men's risk of high blood pressure & heart disease. Results will help us understand & prevent heart disease in prostate cancer survivors.

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.Check my eligibility

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.See study design

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.

ARCH Trial 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.

ARCH Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Cardiovagal Baroreflex Sensitivity

Change in Renal dysfunction biomarkers

Change in ambulatory blood pressure variability

+4 more

Secondary outcome measures

Change in Sympathetic reactivity

Change in glomerular filtration rate

Change in renal plasma flow

+1 more

Other outcome measures

Change in Body composition

Change in Inflammation

Change in Oxidative stress

ARCH 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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,298 Total Patients Enrolled

Matthew Babcock, PhDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants currently being accepted for this experiment?

"Consistent with clinicaltrials.gov, this particular investigation is still in the process of recruiting participants. The trial was initially announced on September 20th 2023 and has been recently revised as of November 14th 2023."

Answered by AI

How many individuals are taking part in this experiment?

"Affirmative. According to the clinicaltrials.gov platform, this medical trial initiated on September 20th of this year is presently recruiting participants. A total of 228 patients must be sourced from a single site before the study can begin in earnest."

Answered by AI

What is the purpose of this research endeavor?

"This medical trial aims to observe the effect of androgen deprivation therapy or placebo over a 9-week period on renal dysfunction biomarkers. The primary outcome will be tracked through changes in glomerular filtration rate, which is carried out using Omnipaque 300 (GE Healthcare) clearance technique. Additionally, sympathetic baroreflex sensitivity is evaluated with modified Oxford procedure while renal plasma flow uses p-aminohippurate (Basic Pharma) clearance techniques that are assessed via HPLC technology (Waters, Milford, MA)."

Answered by AI

What levels of peril does Prostate Cancer pose for individuals?

"Our experts at Power have assigned Prostate cancer a score of 3, demonstrating their confidence in its safety given it has reached Phase 4 of the clinical trial process and been approved."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Contributions to Hypertension With Androgen Deprivation Therapy

2023. "Contributions to Hypertension With Androgen Deprivation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05700903.