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

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

Study Overview

• Status: Recruiting
• Conditions: Elevated Serum PSA
• Intervention / Treatment: Drug: Ibuprofen 400 mg

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Matthew Ho, MD; Phone Number: 17083058691; Email: matthew.ho@uchospitals.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Contact: Matthew Ho, MD; Phone Number: 708-305-8691; Email: Matthew.Ho@uchospitals.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ibuprofen; Participants receive Ibuprofen 400 mg tablet orally every 8 hours for 10 days	Drug: Ibuprofen 400 mg; 400 mg tablet; Other Names: Advil
No Intervention: Control; Participants receive no NSAIDs

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Scott Eggener, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: August 21, 2022
• First Submitted That Met QC Criteria: August 21, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: PSA
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: IRB21-1952

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No