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NCT05512754PHASE4Recruiting

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

University of Chicago

Start Date

8/1/2022

Completion Date

12/31/2027

Summary

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

Detailed Description

Serum prostate-specific antigen (PSA) is widely used as a screening marker for prostate cancer. However, elevated serum PSA level could result from various conditions other than malignancy such as benign prostatic hyperplasia (BPH), urinary tract infection, or inflammation (prostatitis). Inflammation within the prostate is often sub-clinical, not readily visible on urinalysis, and can putatively and artificially elevate PSA. Non-steroidal anti-inflammatory drugs (NSAIDs) have shown benefits in reducing symptoms in patients with inflammatory conditions of the prostate. Ibuprofen (Advil, Motrin) is a widely available, cheap, and commonly used over the counter NSAID. NSAID's are routinely given to men with an elevated PSA for empiric treatment of inflammation; however, the impact of NSAIDs in men with elevated serum PSA is unknown.

Eligibility Criteria

Age Range: 18 years to 80 years

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

Interventions

DRUG

Ibuprofen 400 mg

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Conditions

Elevated Serum PSA

Locations

University of Chicago

Chicago, Illinois 60637

United States

Albany Medical College

Albany, New York 12208

United States

The Pennsylvania State University at The Milton S. Hershey Medical Center

Hershey, Pennsylvania 17033

United States