Using anti-inflammatory drugs to lower PSA levels in men
Effect of Non-steroidal Anti-inflammatory Drugs on Serum Prostate Specific Antigen Level
This study is testing if taking ibuprofen can lower PSA levels in men with high readings to help avoid unnecessary prostate biopsies.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 198 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Albany Medical College Academic / other |
| Locations | 3 sites (Chicago, Illinois and 2 other locations) |
| Trial ID | NCT05629494 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are male patients aged 18-80 with elevated PSA levels who are being considered for additional diagnostic testing.
Not a fit: Patients with a history of hypersensitivity to NSAIDs, severe chronic kidney disease, or active urinary tract infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the number of unnecessary prostate biopsies and associated complications for patients.
How similar studies have performed: While the use of anti-inflammatory drugs for this purpose is not widely tested, there is some preliminary evidence suggesting potential benefits in similar contexts.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Chicago, Illinois and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.