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

• Status: Active, not recruiting
• Trial end date: 2024-07-31
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Ibuprofen

Criteria

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