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

RecruitingPhase 4

Randomized Controlled Trial of Anti-inflammatory Medications in Patients With Elevated Serum Prostate-specific Antigen

Who can join

Ages 18 to 80 · Men

Full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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

About the study

The purpose of this study is to assess the impact of ibuprofen in men with elevated serum PSA.

What is being tested

Sponsor: University of Chicago · Participants: 200 · Started: Aug 1, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05512754

Locations in the U.S.

IllinoisUniversity of Chicago, Chicago
New YorkAlbany Medical College, Albany
PennsylvaniaThe Pennsylvania State University at The Milton S. Hershey Medical Center, Hershey

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.