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Ibuprofen and PSA Test Study for Prostate Health

This study is looking at whether anti-inflammatory medications like ibuprofen can help lower elevated PSA (prostate-specific antigen) levels. An elevated PSA can sometimes lead to unnecessary prostate biopsies, as it can be high due to inflammation, not just cancer. If you are a man between 18 and 80 years old with a PSA level above 3 ng/ml and are being considered for further testing, you might be able to join. Participants will take Ibuprofen 400 mg three times a day for 10 days. The study will then check if your PSA level has decreased to an acceptable level after 6 weeks. The goal is to see if this approach can improve the reliability of PSA tests and help avoid unnecessary procedures.

Study design
This interventional study plans to enroll 198 men. It is not specified if it is randomized or blinded.
What's involved
Participants will take Ibuprofen 400 mg three times a day for 10 days. A PSA test will be repeated 6 weeks after starting the medication.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in PSA level at 6 weeks after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05629494

Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test

Recruiting
PHASE4Ages 18–80InterventionalTreatment
Albany Medical College
~198 participants
Updated 2024-10-18 on ClinicalTrials.gov
What's tested:Ibuprofen 400 mg, TIDPSA test

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difference in the extent of changes in PSA level between the study groups
Measured over 6 weeks
+1 more outcome measured

Conditions

Prostate Cancer
Prostate Inflammation
PSA

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Where it's being run

3 sites across 3 states
Illinois1
New York1
Pennsylvania1

Study leadership

  • Badar Mian, MD · PRINCIPAL_INVESTIGATOR · Albany Medical College
  • Jay Raman, MD · PRINCIPAL_INVESTIGATOR · Penn State Health
  • Scott Eggener, MD · PRINCIPAL_INVESTIGATOR · University of Chicago

Who to contact

Brenda Romeo
[email protected]
518-262-8579
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Difference in the extent of changes in PSA level between the study groups6 weeks

    Difference in PSA levels, within and between groups

  • Participants with change in PSA level to below the age-specific PSA threshold6 weeks

    To determine if changes in PSA level were sufficient to avoid intervention