Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test
Recruiting · NCT05629494 · Interventional (participants receive a specific treatment) · Lead sponsor: Albany Medical College
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Prostate cancer is the most frequently diagnosed cancer in men in the Unites States. Nearly 1 million prostate biopsy procedures are performed in the United States annually and elevated prostate-specific antigen (PSA) level is the primary reason for prostate biopsy in \> 90% of cases. However, at the PSA levels which trigger prostate biopsy, often no cancer is found in prostate biopsy specimens. PSA test can be elevated due to reasons other than cancer such as inflammation or natural variation in the level. Investigators plan to treat men with elevated PSA level with over the counter anti-inflammatory medications (ibuprofen, naproxen) to see if the PSA level will decrease to an acceptable level.
Who can take part
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 is running
3 locations listed across 3 US states.
- University of Chicago Medical Center - Chicago, Illinois, United States
- Albany Medical Center - Albany, New York, United States
- Penn State-Hershey Medical Center - Hershey, Pennsylvania, United States