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

December 2, 2025 updated by: University of Chicago

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical College
        • Contact:
        • Contact:
        • Principal Investigator:
          • Badar Mian, MD
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 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)
  • Patients with a solitary kidney or history of a kidney transplant
  • Any other medical contraindication to NSAIDs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Baseline, 6 weeks
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
Time Frame: Baseline, 6 weeks

Self-reported questionnaires measured lower urinary tract symptoms ranging from 0 to 35.

Higher score mean worse outcomes.
Baseline, 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

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)

December 9, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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