NCT05512754

Impact of Anti-inflammatory Medications in Patients With Elevated Serum Prostate-specific Antigen

Randomized Controlled Trial of Anti-inflammatory Medications in Patients With Elevated Serum Prostate-specific Antigen

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the impact of ibuprofen in men with elevated serum PSA.

Detailed description

Serum prostate-specific antigen (PSA) is widely used as a screening marker for prostate cancer. However, elevated serum PSA level could result from various conditions other than malignancy such as benign prostatic hyperplasia (BPH), urinary tract infection, or inflammation (prostatitis). Inflammation within the prostate is often sub-clinical, not readily visible on urinalysis, and can putatively and artificially elevate PSA. Non-steroidal anti-inflammatory drugs (NSAIDs) have shown benefits in reducing symptoms in patients with inflammatory conditions of the prostate. Ibuprofen (Advil, Motrin) is a widely available, cheap, and commonly used over the counter NSAID. NSAID's are routinely given to men with an elevated PSA for empiric treatment of inflammation; however, the impact of NSAIDs in men with elevated serum PSA is unknown.

Conditions

• Elevated Serum PSA

Interventions

Type	Name	Description
DRUG	Ibuprofen 400 mg	400 mg tablet

Timeline

• Start date: 2022-08-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2022-08-23
• Last updated: 2025-12-09

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study