Using anti-inflammatory drugs to lower PSA levels in men

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effect of over-the-counter anti-inflammatory medications, specifically ibuprofen, on prostate-specific antigen (PSA) levels in men with elevated PSA readings. The goal is to determine if these medications can reduce PSA levels sufficiently to avoid unnecessary prostate biopsies, which often do not reveal cancer. Participants will be male patients aged 18-80 with a PSA level greater than 3 ng/ml who are being considered for further diagnostic testing. The study aims to improve the reliability of PSA testing and reduce the risks associated with unnecessary biopsies.

Why it matters

Who can join: the full rules

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 within the past two years. A documented normal digital rectal examination by another physician or advanced practice provider (NP, PA, etc) is acceptable.
* No clinical symptoms concerning for acute urinary tract infection (e.g. dysuria, malodorous urine, positive urine culture)

Exclusion Criteria:

* History of hypersensitivity or allergy to ibuprofen or NSAIDs.
* History of peptic ulcer disease, GI bleeding or NSAIDs induced GI adverse events
* Known bleeding disorders
* Known severe chronic kidney disease: eGFR \< 30 mL/min/1.73 m2
* Heart failure, significant heart disease
* Poorly controlled hypertension
* Active urinary tract infections or bacteriuria
* Concomitant use of 5-alpha reductase inhibitors (finasteride, dutasteride) unless patient has been taking it for at least 6 months
* Known prostate cancer or underwent prostate MRI or biopsy in the last year
* Urinary tract instrumentation in the past 6 weeks (catheter, cystoscopy)
* Concomitant anti-inflammatory or steroidal drugs
* Concomitant dual-antiplatelet or anticoagulant therapy use except aspirin 81 mg alone
* Know history of severe liver disease determined by abnormal liver function tests (elevated AST or ALT \> 3X ULN based on exiting history or labs)
* Any other medical contraindication to NSAIDs

Where it's running

• University of Chicago Medical Center
  Chicago, Illinois, United States Recruiting
• Albany Medical Center
  Albany, New York, United States Recruiting
• Penn State-Hershey Medical Center
  Hershey, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Badar Mian, MD — Albany Medical College
• Study coordinator: Brenda Romeo
• Email: amcurologyresearch@amc.edu
• Phone: 518-262-8579

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.