Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18-80
SponsorAlbany Medical College
About this trial
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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ibuprofen 400 mg, TID
- PSA test
Treatment groups
198 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov