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

Phase 4

Recruiting

• Conditions: Elevated Serum PSA
• Interventions: Drug: Ibuprofen 400 mg

• Registration Number: NCT05512754
• Lead Sponsor: University of Chicago

Brief 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.

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-08-21
• Study First Submitted QC: 2022-08-21
• Study First Posted: 2022-08-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

• 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.
• No clinical symptoms concerning acute urinary tract infection (e.g. dysuria, malodorous urine, positive urine culture)

Exclusion Criteria

• Active urinary tract infections or bacteriuria
• Known prostate cancer
• Urethral catheter within the last 6 weeks
• History of hypersensitivity or allergy to ibuprofen or NSAIDs.
• Known severe chronic kidney disease: eGFR < 30 mL/min/1.73 m2
• Known history of severe liver disease (elevated AST or ALT greater than 3 times upper limit of normal)
• History of gastrointestinal bleeding or NSAIDs induced GI adverse events
• Concomitant dual-antiplatelet use or anticoagulants
• Concomitant anti-inflammatory or steroidal drugs
• Known bleeding disorder(s)
• Patients with a solitary kidney or history of a kidney transplant
• Any other medical contraindication to NSAIDs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen	Ibuprofen 400 mg	Participants receive Ibuprofen 400 mg tablet orally every 8 hours for 10 days

Primary Outcome Measures

Name	Time	Method
Change of serum PSA compared with baseline	Baseline, 6 weeks	serum prostatic specific antigen

Secondary Outcome Measures

Name	Time	Method
Change of International Prostate Symptom Score (IPSS) compared with baseline	Baseline, 6 weeks	Self-reported questionnaires measured lower urinary tract symptoms ranging from 0 to 35.; Higher score mean worse outcomes.

Trial Locations

Locations (3)

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Albany Medical College; 🇺🇸 Albany, New York, United States

The Pennsylvania State University at The Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States