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

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

Recruiting
18-80 years
Male
Phase 4

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Overview

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

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

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)
  • Any other medical contraindication to NSAIDs

Study details
    Elevated Serum PSA

NCT05512754

University of Chicago

16 February 2024

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