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Recruiting Phase 4 NCT05512754

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

Trial Parameters

Condition Elevated Serum PSA
Sponsor University of Chicago
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 200
Sex MALE
Min Age 18 Years
Max Age 80 Years
Start Date 2022-08-01
Completion 2027-12-31
Interventions
Ibuprofen 400 mg

Brief Summary

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

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 contra

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