Actively Recruiting
Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test
Led by Albany Medical College · Updated on 2024-10-18
198
Participants Needed
3
Research Sites
218 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 to 80 years with screening PSA greater than 3 ng/ml considered for further testing
- Normal digital rectal examination within the past two years, documented by a physician or advanced practice provider
- No symptoms suggesting acute urinary tract infection such as painful urination or positive urine culture
You will not qualify if you...
- Allergy or hypersensitivity to ibuprofen or NSAIDs
- History of peptic ulcer disease, gastrointestinal bleeding, or NSAID-induced gastrointestinal side effects
- Known bleeding disorders
- Severe chronic kidney disease with eGFR less than 30 mL/min/1.73 m2
- Heart failure or significant heart disease
- Poorly controlled high blood pressure
- Active urinary tract infections or bacteriuria
- Use of 5-alpha reductase inhibitors unless taken continuously for at least 6 months
- Known prostate cancer or prostate MRI or biopsy within the past year
- Urinary tract procedures like catheter or cystoscopy within the past 6 weeks
- Use of anti-inflammatory or steroid drugs concurrently
- Use of dual antiplatelet or anticoagulant therapy except aspirin 81 mg alone
- Severe liver disease with liver function tests elevated more than 3 times normal
- Any other medical reason preventing use of NSAIDs
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
2
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
3
Penn State-Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
Research Team
B
Brenda Romeo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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