Randomized Controlled Trial of Anti-inflammatory Medications in Patients With Elevated Serum Prostate-specific Antigen
University of Chicago
Summary
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)…
Eligibility
- Age range
- 18–80 years
- Sex
- Male
- Healthy volunteers
- No
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 * Kno…
Interventions
- DrugIbuprofen 400 mg
400 mg tablet
Locations (3)
- University of ChicagoChicago, Illinois
- Albany Medical CollegeAlbany, New York
- The Pennsylvania State University at The Milton S. Hershey Medical CenterHershey, Pennsylvania