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Recruiting NCT05512754

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

Phase IV Interventional Elevated Serum PSA

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ibuprofen 400 mg.
Who it may be relevant to
Registry conditions: Elevated Serum PSA. Basic parameters: 18 years — 80 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • Drug Ibuprofen 400 mg
    400 mg tablet

Primary outcome measures

  • Change of serum PSA compared with baseline [Time frame: Baseline, 6 weeks]
Secondary outcome measures (1)
  • Change of International Prostate Symptom Score (IPSS) compared with baseline [Time frame: Baseline, 6 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • University of Chicago — Chicago
  • Albany Medical College — Albany
  • The Pennsylvania State University at The Milton S. Hershey Medical Center — Hershey

Publications

  • 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
  • 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

Identifiers

NCT: NCT05512754 · IRB21-1952

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗