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Recruiting

NCT Number: NCT05512754

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

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

Recruiting

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

University of Chicago, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen 400 mg

Drug

400 mg tablet

Other names: Advil

Primary outcomes

  1. Change of serum PSA compared with baseline

    Time frame: Baseline, 6 weeks

    serum prostatic specific antigen

Secondary outcomes

  1. Change of International Prostate Symptom Score (IPSS) compared with baseline

    Time frame: Baseline, 6 weeks

    Self-reported questionnaires measured lower urinary tract symptoms ranging from 0 to 35.

    Higher score mean worse outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Leila Yazdanbakhsh, MSCI

CONTACT

[email protected]

7738345087

Scott Eggener, MD

CONTACT

[email protected]

773-834-5087

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Randomized Controlled Trial of Anti-inflammatory Medications in Patients With Elevated Serum Prostate-specific Antigen

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 23, 2022
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.