💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
💊
What it tests
- Ibuprofen 400 mg, TID
- PSA test
University of Chicago Medical Center
Chicago, United States
Albany Medical Center
Albany, United States
Penn State-Hershey Medical Center
Hershey, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky