Effect of ibuprofen on elevated PSA levels in men
Official title: Randomized Controlled Trial of Anti-inflammatory Medications in Patients With Elevated Serum Prostate-specific Antigen
Run by University of Chicago · NCT05512754 · Data updated 2026-11-12
This study is testing whether taking ibuprofen can lower high PSA levels in men who might need more tests for prostate issues.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | Men only |
| Enrollment | 200 (estimated) |
| Sponsor | University of Chicago Academic / other |
| Locations | 3 sites (Chicago, Illinois and 2 other locations) |
| Status | Recruiting |
| Started | August 1, 2022 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | December 9, 2025 |
| Trial ID | NCT05512754 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are male patients aged 18-80 with elevated PSA levels and no clinical symptoms of urinary tract infection.
✕Probably not a fit
Patients with active urinary tract infections, known prostate cancer, or severe chronic kidney disease are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the impact of ibuprofen, a common over-the-counter anti-inflammatory medication, on men with elevated serum prostate-specific antigen (PSA) levels. Elevated PSA can indicate various conditions, including benign prostatic hyperplasia and inflammation, rather than prostate cancer. The study aims to determine if ibuprofen can reduce PSA levels in patients who are being considered for further diagnostic testing. Participants will be male patients aged 18-80 with a PSA greater than 3 ng/ml and a normal digital rectal examination.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive treatment option to lower PSA levels and reduce unnecessary diagnostic procedures.
How similar studies have gone: While the use of NSAIDs for prostate inflammation is common, this specific approach to assess ibuprofen's impact on PSA levels is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Chicago
Chicago, Illinois, United States Recruiting -
Albany Medical College
Albany, New York, United States Recruiting -
The Pennsylvania State University at The Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Scott Eggener, MD — University of Chicago
- Study coordinator: Scott Eggener, MD
- Email: seggener@bsd.uchicago.edu
- Phone: 773-834-5087
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.