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Nonsteroidal Anti-inflammatory Drug

Anti-inflammatory Drugs for Elevated Prostate-Specific Antigen Levels (ADAPT-PSA Trial)

Phase 4
Recruiting
Led By Scott Eggener, MD
Research Sponsored by Albany Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Steroids use (except occasionally inhaled formulations)
History of prostate cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 to 1.5 year
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test whether anti-inflammatory drugs can lower PSA levels in men w/ elevated PSA, reducing unnecessary prostate biopsies.

Who is the study for?
Men with elevated PSA levels, which could indicate prostate issues, are eligible for this trial. They must not have bleeding disorders, severe kidney disease, recent urinary tract procedures, or be on certain medications like steroids and blood thinners. Men with a history of prostate cancer or current signs of urinary infection cannot join.
What is being tested?
The study is testing if common anti-inflammatory drugs (Ibuprofen or Naproxen) can lower high PSA levels in men to avoid unnecessary biopsies. The effect of these over-the-counter medications on PSA will be monitored closely.
What are the potential side effects?
Possible side effects from Ibuprofen or Naproxen include stomach upset or pain, heartburn, gastrointestinal bleeding, kidney problems, increased blood pressure and potential risk for heart attack or stroke.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not use steroids regularly, except for asthma or COPD.
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I have a history of prostate cancer.
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I have liver disease or abnormal liver tests.
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I am experiencing symptoms of a urinary tract infection.
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I regularly use NSAIDs more than once a week.
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I am taking medication to prevent blood clots.
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I cannot take NSAIDs due to allergies or side effects.
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I have had stomach ulcers or bleeding in my digestive tract.
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My kidney function is reduced with an eGFR below 45.
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I have heart failure or significant heart disease.
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I have a bleeding disorder.
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My high blood pressure is not well-managed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 to 1.5 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 to 1.5 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in the extent of changes in PSA level between the study groups
Participants with change in PSA level to below the age-specific PSA threshold
Secondary study objectives
Changes in voiding symptoms as measured by the International Prostate Symptom Score
Determine the incidence of acute kidney injury following a short course of ibuprofen
Durability of the change in PSA levels

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment with NSAIDSExperimental Treatment2 Interventions
Treatment with Ibuprofen 400 mg, 3 times per day, then repeat PSA test at 6 (± 1) weeks
Group II: Repeat serum PSA testActive Control1 Intervention
Repeat PSA test at 6 (± 1) weeks, without any treatment

Find a Location

Who is running the clinical trial?

Albany Medical CollegeLead Sponsor
94 Previous Clinical Trials
12,363 Total Patients Enrolled
Scott Eggener, MDPrincipal InvestigatorUniversity of Chicago
5 Previous Clinical Trials
712 Total Patients Enrolled
Jay Raman, MDPrincipal InvestigatorPenn State Health

Media Library

Ibuprofen or Naproxen (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT05629494 — Phase 4
Prostatitis Research Study Groups: Repeat serum PSA test, Treatment with NSAIDS
Prostatitis Clinical Trial 2023: Ibuprofen or Naproxen Highlights & Side Effects. Trial Name: NCT05629494 — Phase 4
Ibuprofen or Naproxen (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05629494 — Phase 4
~72 spots leftby Mar 2026
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