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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
- Ibuprofen 400 mg (drug)
Sponsor: University of Chicago · Participants: 200 · Started: Aug 1, 2022
Contact the study team
- Scott Eggener, MD · Phone: 773-834-5087
- Leila Yazdanbakhsh, MSCI · Phone: 7738345087
Official record on ClinicalTrials.gov — NCT05512754
Locations in the U.S.
| Illinois | University of Chicago, Chicago |
| New York | Albany Medical College, Albany |
| Pennsylvania | The 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.