Actively Recruiting
Effect of Non-steroidal Anti-inflammatory Drugs on Serum Prostate Specific Antigen Level
Led by Albany Medical College · Updated on 2024-10-18
198
Participants Needed
3
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prostate cancer is the most commonly diagnosed cancer in men in the United States. Many men undergo prostate biopsy due to elevated prostate-specific antigen (PSA) levels, but often no cancer is found. Elevated PSA levels can result from inflammation, benign prostate enlargement, infections, or natural variations. This research aims to study whether over-the-counter anti-inflammatory drugs like ibuprofen or naproxen can lower PSA levels and potentially reduce unnecessary biopsies. Participants are randomly assigned to one of two groups. One group will have a repeat PSA test after about 6 weeks without treatment, while the other group will take ibuprofen 400 mg three times daily for 10 days before repeating the PSA test at around 6 weeks. The study compares changes in PSA levels between these groups to understand the effect of anti-inflammatory medications. During the study, participants will have PSA tests, and their symptoms will be monitored using questionnaires like the International Prostate Symptom Score over 3 to 12 months. Researchers will track kidney function to identify any risks from ibuprofen use and assess how long any changes in PSA levels last up to 1.5 years. The goal is to identify safer ways to manage elevated PSA levels and avoid unnecessary procedures. Total participation may extend up to a year or more for follow-up assessments.
CONDITIONS
Brief Title
Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients between 18 and 80 years old with a screening PSA greater than 3 ng/ml considered for further testing
- Normal digital rectal examination within the past two years, documented by a healthcare provider
- No symptoms suggesting an acute urinary tract infection such as painful or unusual urination
You will not qualify if you...
- Allergy or hypersensitivity to ibuprofen or other NSAIDs
- History of peptic ulcers, gastrointestinal bleeding, or NSAID-related gastrointestinal problems
- 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 bacteria in urine
- Use of 5-alpha reductase inhibitors unless on stable dose for at least 6 months
- Known prostate cancer or recent prostate MRI or biopsy within one year
- Urinary tract procedures like catheter or cystoscopy in past 6 weeks
- Use of anti-inflammatory or steroid drugs concurrently
- Use of dual-antiplatelet or anticoagulant therapy except low-dose aspirin
- Severe liver disease shown by abnormal liver tests
- Any other medical condition that contraindicates NSAID use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 days
Participants receive Ibuprofen 400 mg three times per day for 10 days.
1 treatment period of 10 days
Duration - 6 weeks (± 1 week)
Participants who do not receive treatment will have their PSA level repeated after 6 weeks.
1 follow-up visit for PSA test
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
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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