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

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Description

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

Targeted Conditions

Study Overview

Start Date
August 1, 2022
Completion Date
July 31, 2024
Enrollment
200
Date Posted
August 23, 2022
Accepts Healthy Volunteers?
No
Gender
Male

Locations

Full Address
University of Chicago
Chicago, Illinois 60637, United States

Eligibility

Minimum Age (years)
18
Maximum Age (years)
80
Eligibility 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

Study Contact Info

Study Contact Name
Matthew Ho, MD
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
Detailed 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.
NCTid (if applicable)
NCT05512754