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

Recruiting now · Phase 4

Conditions studied: Elevated Serum PSA

In brief

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

Key facts

Study ID

NCT05512754

Run by

University of Chicago

People needed

200

Starts

2022-08-01

Expected to finish

2027-12-31

Last updated by the study team

2025-12-09

Who can join

Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 is running

• University of Chicago — Chicago, Illinois, United States (enrolling)
• Albany Medical College — Albany, New York, United States (enrolling)
• The Pennsylvania State University at The Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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