NCT05629494

Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test

Effect of Non-steroidal Anti-inflammatory Drugs on Serum Prostate Specific Antigen Level

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Albany Medical College · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

It's known that PSA level can be elevated due to reasons other than prostate cancer including benign prostatic hypertrophy, prostatitis or other urinary tract infections, non-infectious inflammation, and physiologic variation over time. Consequently, nearly 50% of prostate biopsy procedures performed due to elevated PSA level do not yield any cancer , but still expose the patients to the risks of the procedure related complications (discomfort/pain, anxiety, bleeding, infection, and cost). Thus, measures to improve the reliability of PSA test, and potentially avoiding unnecessary procedures, are of significant importance to the patient and healthcare system. It is common practice to check PSA level annually. PSA test results can vary over time, either due to the imprecision in the analysis and/or due to the biologic variability. This can result in an apparent rise in PSA level when no clinically meaningful rise had occurred. Its estimated that the average lab variation in PSA was approximately 6% and the average biologic variation about 14%. This, it is recommended that isolated elevation in PSA level should be confirmed after several weeks, and before proceeding with further interventions, including prostate biopsy. Sub-clinical, histologic Inflammation (presence of inflammatory cells) within the prostate tissue and its effect on PSA level has been reported in various settings. In two population-based studies, men who were regularly using over the counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs, e.g ibuprofen, naproxen) had lower PSA levels compared to non-users. Currently, two strategies are utilized in clinical practice to ensure that the PSA level is truly elevated: 1. Repeat PSA test after several weeks or 2. A short course of OTC NSAIDs, and then repeat PSA test Investigators propose to conduct a randomized study to determine the effect of NSAIDs on PSA level compared to the biologic variations in PSA level noted upon repeat testing.

Conditions

• Prostate Cancer
• Prostate Inflammation
• PSA

Interventions

Type	Name	Description
DRUG	Ibuprofen 400 mg, TID	Participants will receive Ibuprofen 400 mg 3 times per day for 10 days.
DIAGNOSTIC_TEST	PSA test	PSA test will be repeated in 6 weeks

Timeline

• Start date: 2022-09-27
• Primary completion: 2026-03-01
• Completion: 2026-12-01
• First posted: 2022-11-29
• Last updated: 2024-10-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study