RecruitingPhase 4NCT05512754
Impact of Anti-inflammatory Medications in Patients With Elevated Serum Prostate-specific Antigen
Randomized Controlled Trial of Anti-inflammatory Medications in Patients With Elevated Serum Prostate-specific Antigen
Sponsor
University of Chicago
Enrollment
200 participants
Start Date
Aug 1, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to assess the impact of ibuprofen in men with elevated serum PSA.
Eligibility
Sex: MALEMin Age: 18 YearsMax Age: 80 Years
Inclusion Criteria3
- 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 Criteria12
- 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
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Interventions
DRUGIbuprofen 400 mg
400 mg tablet
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05512754