Ibuprofen for Elevated PSA

This study is looking at how ibuprofen (Advil, Motrin) affects men who have elevated prostate-specific antigen (PSA) levels. PSA is a marker often used to screen for prostate cancer, but it can also be high due to other issues like inflammation. Researchers want to see if ibuprofen, a common anti-inflammatory medication, can lower PSA levels. You might be able to join if you are a man between 18 and 80 years old with a PSA level above 3 ng/ml and are being considered for further testing like an MRI or biopsy. The main goal is to measure the change in your PSA level after 6 weeks of treatment. The study's current status is unclear, and it plans to enroll 200 participants.

Study design
This interventional study plans to enroll 200 men. It is not specified if it is randomized or blinded, or what phase it is in.
What's involved
You would take 400 mg ibuprofen tablets. Your PSA levels would be measured at the beginning of the study and again after 6 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your PSA levels will be measured at baseline and again at 6 weeks.

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NCT05512754

Impact of Anti-inflammatory Medications in Patients With Elevated Serum Prostate-specific Antigen

Recruiting
PHASE4Ages 18–80InterventionalTreatment
University of Chicago
~200 participants
Updated 2025-12-09 on ClinicalTrials.gov
What's tested:Ibuprofen 400 mg

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change of serum PSA compared with baseline
Measured over Baseline, 6 weeks
Elevated Serum PSA
3 sites across 3 states
Illinois1
New York1
Pennsylvania1
  • Scott Eggener, MD · PRINCIPAL_INVESTIGATOR · University of Chicago

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Eligibility criteria

Inclusion

Male patients age between 18-80 years old with a screening PSA \> 3 ng/ml being considered for additional diagnostic testing (e.g., MRI, biopsy)
Normal digital rectal examination.
No clinical symptoms concerning acute urinary tract infection (e.g. dysuria, malodorous urine, positive urine culture)

Exclusion

Active urinary tract infections or bacteriuria
Known prostate cancer
Urethral catheter within the last 6 weeks
History of hypersensitivity or allergy to ibuprofen or NSAIDs.
Known severe chronic kidney disease: eGFR \< 30 mL/min/1.73 m2
Known history of severe liver disease (elevated AST or ALT greater than 3 times upper limit of normal)
History of gastrointestinal bleeding or NSAIDs induced GI adverse events
Concomitant dual-antiplatelet use or anticoagulants
Concomitant anti-inflammatory or steroidal drugs
Known bleeding disorder(s)
Patients with a solitary kidney or history of a kidney transplant
Any other medical contraindication to NSAIDs
  • Change of serum PSA compared with baselineBaseline, 6 weeks

    serum prostatic specific antigen