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

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

Detailed Description
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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.

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

Conditions
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Elevated Serum PSA

Intervention / Treatment
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* Drug: Ibuprofen 400 mg


Participation Criteria
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Eligibility Criteria
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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) Any other medical contraindication to NSAIDs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization into two groups between Group A (No NSAIDs) or Group B (Ibuprofen 400 mg q 8 h for 10 days)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibuprofen<br>Participants receive Ibuprofen 400 mg tablet orally every 8 hours for 10 days | Drug: Ibuprofen 400 mg<br>* 400 mg tablet<br>* Other names: Advil;|
| No Intervention: Control<br>Participants receive no NSAIDs | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of serum PSA compared with baseline | serum prostatic specific antigen | Baseline, 6 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PSA