ARAT for Acid Reflux

(AREA21 Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Prateek Sharma, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Midwest Veterans' Biomedical Research Foundation

Must not be taking: PPI medications

Disqualifiers: Hiatal hernia, Barrett's esophagus, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This will be a randomized clinical trial examining the efficacy and safety of ARAT (intervention group) in patients with chronic GERD symptoms (typical symptoms of GERD, i.e. heartburn or acid reflux/regurgitation at least twice a week) for the last 6 months. Patients must have a positive pH test and a negative manometry (no treatment) procedure.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is ARAT treatment generally safe for humans?

ARAT treatments like abiraterone, enzalutamide, apalutamide, and darolutamide have been used for prostate cancer and can cause side effects like changes in hormone levels, muscle loss, and effects on the brain. However, these treatments are generally considered safe for use in humans, with side effects being monitored and managed by healthcare providers.

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Eligibility Criteria

This trial is for adults aged 18-80 with chronic GERD, experiencing heartburn or acid reflux at least twice a week for the past 6 months. They must have confirmed acid reflux via a pH test but no major esophagus movement issues. Excluded are those with certain esophageal conditions, previous surgeries, severe liver disease, allergies to PPIs, and very large hiatal hernias.

Inclusion Criteria

Objective evidence of reflux disease (positive ambulatory pH study)

I have had heartburn or acid reflux at least twice a week for the last 6 months.

Exclusion Criteria

Allergic or intolerant to PPI medications

I have a large hiatal hernia over 3 cm and it's very severe.

I am younger than 18 or older than 80.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive anti-reflux mucosal ablation using hybrid argon plasma coagulation

12 months

Multiple visits (in-person) at 3, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up assessments at 3, 6, and 12 months

Participant Groups

The AREA Study is testing ARAT's effectiveness in treating chronic GERD symptoms against a sham (fake) procedure as control. Participants will be randomly assigned to either receive ARAT or the sham intervention to compare outcomes.

Group I: Anti-reflux mucosal ablation (ARAT) Active Control 1 Intervention

ablation in the gastric cardia using hybrid argon plasma coagulation

Group II: No treatment Placebo Group 1 Intervention

no ablation

ARAT is already approved in United States, European Union, Japan, Canada for the following indications:

🇺🇸 Approved in United States as Abiraterone for:

• Metastatic castration-resistant prostate cancer
• Metastatic castration-sensitive prostate cancer

🇪🇺 Approved in European Union as Enzalutamide for:

• Metastatic castration-resistant prostate cancer
• Non-metastatic castration-resistant prostate cancer

🇯🇵 Approved in Japan as Apalutamide for:

• Metastatic castration-sensitive prostate cancer
• Non-metastatic castration-resistant prostate cancer

🇨🇦 Approved in Canada as Darolutamide for:

• Non-metastatic castration-resistant prostate cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Kansas City VA Hospital Kansas City, MO

Who Is Running the Clinical Trial?

Midwest Veterans' Biomedical Research Foundation Lead Sponsor

References

1. Canada pubmed.ncbi.nlm.nih.gov

A comparison of the sarcopenic effect of androgen receptor-axis-targeted agents vs. androgen deprivation alone in patients with metastatic prostate cancer. [2023] Androgen deprivation therapy (ADT) with androgen receptor axis-targeted (ARAT) therapy is the standard of care provided to patients with metastatic prostate cancer. While effective, it results in sequelae, such as loss of skeletal muscle mass. In this study, we compared the sarcopenic effects of abiraterone and enzalutamide, two ARATs used to treat metastatic prostate cancer.

2. United States pubmed.ncbi.nlm.nih.gov

Indirect Comparison of Darolutamide versus Apalutamide and Enzalutamide for Nonmetastatic Castration-Resistant Prostate Cancer. [2021] No published head-to-head randomized trials have compared the safety and efficacy of darolutamide vs apalutamide or enzalutamide in nonmetastatic castration-resistant prostate cancer. This study compares prespecified adverse events and metastasis-free survival associated with darolutamide vs apalutamide, and darolutamide vs enzalutamide, via matching-adjusted indirect comparisons.

3. Switzerland pubmed.ncbi.nlm.nih.gov

Endocrine consequences of treatment with the new androgen receptor axis-targeted agents for advanced prostate cancer. [2021] Prostate cancer (PCa) is the commonest non-cutaneous malignancy worldwide and the second cause of cancer death among males in the USA. Approval of the new androgen receptor axis-targeted (ARAT) agents (abiraterone acetate, enzalutamide, apalutamide, and darolutamide) has altered the course of advanced PCa. We aimed to assess the endocrine and metabolic adverse events associated with treatment using ARAT compounds.

4. Germany pubmed.ncbi.nlm.nih.gov

Managing lines of therapy in castration-resistant prostate cancer: real-life snapshot from a multicenter cohort. [2021] To provide a snapshot of toxicities and oncologic outcomes of Abiraterone (AA) and Enzalutamide (EZ) in a chemo-naïve metastatic castration-resistant prostate cancer (mCPRC) population from a longitudinal real-life multicenter cohort.

5. France pubmed.ncbi.nlm.nih.gov

Comparison of Cerebral Blood Flow in Regions Relevant to Cognition After Enzalutamide, Darolutamide, and Placebo in Healthy Volunteers: A Randomized Crossover Trial. [2023] Off-target central nervous system (CNS) effects are associated with androgen receptor (AR)-targeting treatments for prostate cancer. Darolutamide is a structurally distinct AR inhibitor with low blood-brain barrier penetration.