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

Last updated: March 25, 2025
Sponsor: University of Chicago
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Ibuprofen 400 mg

Clinical Study ID

NCT05512754
IRB21-1952
  • Ages 18-80
  • Male

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male patients age between 18-80 years old with a screening PSA > 3 ng/ml beingconsidered 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

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 timesupper 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

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Ibuprofen 400 mg
Phase: 4
Study Start date:
August 01, 2022
Estimated Completion Date:
December 01, 2025

Study 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.

Connect with a study center

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Albany Medical College

    Albany, New York 12208
    United States

    Active - Recruiting

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

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

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