Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albany Medical College
• Treatments: Ibuprofen; Naproxen

Criteria

Inclusion Criteria:

• All men with an elevated PSA level (as designated by their medical provider) will be invited to participate in the study

Exclusion Criteria:

• Inability to use NSAIDs (allergy, side effects)

• History of peptic ulcer disease or GI bleeding

• Any bleeding disorders

• Chronic kidney disease: eGlomerular Filtration Rate < 45

• Heart failure, significant heart disease

• Poorly controlled hypertension

• Signs or symptoms of urinary tract infections

• Use of 5-alpha reductase inhibitors (finasteride, dutasteride) within past 6 months

• History of prostate cancer

• Urinary 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 period

• Other anti-platelet or anticoagulant therapy

• Steroids use (except occasionally inhaled formulations)

• Liver disease, abnormal liver function tests