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

NCT05512754 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB21-1952
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Elevated Serum PSA

Keywords

PSA

Outcome Measures

Primary Outcomes (1)

• Change of serum PSA compared with baseline

  serum prostatic specific antigen

  Baseline, 6 weeks

Secondary Outcomes (1)

• Change of International Prostate Symptom Score (IPSS) compared with baseline

  Baseline, 6 weeks

Study Arms (2)

Ibuprofen

EXPERIMENTAL

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

Drug: Ibuprofen 400 mg

Control

NO INTERVENTION

Participants receive no NSAIDs

Interventions

Ibuprofen 400 mg DRUG

400 mg tablet

Also known as: Advil

Ibuprofen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (3)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Albany Medical College

Albany, New York, 12208, United States

RECRUITING

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

Hershey, Pennsylvania, 17033, United States

RECRUITING

Related Publications (2)

• Josefsson A, Mansson M, Kohestani K, Spyratou V, Wallstrom J, Hellstrom M, Lilja H, Vickers A, Carlsson SV, Godtman R, Hugosson J. Performance of 4Kscore as a Reflex Test to Prostate-specific Antigen in the GOTEBORG-2 Prostate Cancer Screening Trial. Eur Urol. 2024 Sep;86(3):223-229. doi: 10.1016/j.eururo.2024.04.037. Epub 2024 May 20.

  PMID: 38772787 BACKGROUND

• Aguiar JA, Li EV, Ho A, Bennett R 4th, Li Y, Neill C, Schaeffer EM, Patel HD, Ross AE. Ultrasensitive PSA: rethinking post-surgical management for node positive prostate cancer. Front Oncol. 2024 Apr 9;14:1363009. doi: 10.3389/fonc.2024.1363009. eCollection 2024.

  PMID: 38655143 BACKGROUND

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Scott Eggener, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott Eggener, MD

CONTACT

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

Leila Yazdanbakhsh, MSCI

CONTACT

7738345087; leila.yazdanbakhsh@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization into two groups between Group A (No NSAIDs) or Group B (Ibuprofen 400 mg q 8 h for 10 days)

Study Record Dates

• First Submitted: August 21, 2022
• First Posted: August 23, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

US (3)