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NCT05629494
Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test
Conditions: Prostate Cancer, Prostate Inflammation, PSA
Sex: Male
Ages: 18 Years – 80 Years
Phase: PHASE4
Enrollment: 398
Sponsor: Albany Medical College
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:All men with an elevated PSA level (as designated by their medical provider) will be invited to participate in the studyExclusion Criteria:Inability to use NSAIDs (allergy, side effects)History of peptic ulcer disease or GI bleedingAny bleeding disordersChronic kidney disease: eGlomerular Filtration Rate < 45Heart failure, significant heart diseasePoorly controlled hypertensionSigns or symptoms of urinary tract infectionsUse of 5-alpha reductase inhibitors (finasteride, dutasteride) within past 6 monthsHistory of prostate cancerUrinary tract instrumentation in the past 2 months (catheter, endoscopy)Regular NSAIDs use (> once per week)Daily Aspirin use (325 mg or 81 mg), UNLESS it can be held for the study periodOther anti-platelet or anticoagulant therapySteroids use (except occasionally inhaled formulations)Liver disease, abnormal liver function tests
Source: ClinicalTrials.gov (NCT05629494). StuddyBuddy aggregates publicly available trial information.