Recruiting

Anti-inflammatory Medications

Sponsor:

University of Chicago

Code:

NCT05512754

Conditions

Elevated Serum PSA

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ibuprofen 400 mg

Study Details

Brief summary:

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

Conditions

Elevated Serum PSA

Study ID

NCT05512754

Start date

Aug 1, 2022

Status verified date

Dec, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ibuprofen

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

no intervention: Control

Participants receive no NSAIDs

Interventions

Ibuprofen 400 mg

400 mg tablet

Primary outcome measure

  • Change of serum PSA compared with baseline [ Time Frame: Baseline, 6 weeks ]

Central Contacts and Locations

Central contacts

Scott Eggener, MD

773-834-5087seggener@bsd.uchicago.edu

Leila Yazdanbakhsh, MSCI

7738345087leila.yazdanbakhsh@bsd.uchicago.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Scott Eggener, MD

773-834-5087seggener@bsd.uchicago.edu

Leila Yazdanbakhsh, MSCI

7738345087leila.yazdanbakhsh@bsd.uchicago.edu

Principal Investigator:

Scott Eggener, MD

Albany Medical College

Recruiting

Albany, New York, United States, 12208

Contacts

Badar Mian, MD

518-262-8579amcurologyresearch@amc.edu

Brenda Romeo

romeob@amc.edu

Principal Investigator:

Badar Mian, MD

The Pennsylvania State University at The Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Jay Raman, MD

717-531-8848jraman@pennstatehealth.psu.edu

Dennis Head

dhead@pennstatehealth.psu.edu

Principal Investigator:

Jay Raman, MD

More Information

Sponsor

University of Chicago

Last update posted

Dec 9, 2025

Last verified

Dec, 2025

Keywords

  • PSA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-12-09.