Impact of Anti-inflammatory Medications in Patients With Elevated Serum Prostate-specific Antigen
NCT ID: NCT05512754
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
200 participants
INTERVENTIONAL
2022-08-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ibuprofen
Participants receive Ibuprofen 400 mg tablet orally every 8 hours for 10 days
Ibuprofen 400 mg
400 mg tablet
Control
Participants receive no NSAIDs
No interventions assigned to this group
Interventions
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Ibuprofen 400 mg
400 mg tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Normal digital rectal examination.
* No clinical symptoms concerning acute urinary tract infection (e.g. dysuria, malodorous urine, positive urine culture)
Exclusion Criteria
* 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
18 Years
80 Years
MALE
No
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Scott Eggener, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago
Chicago, Illinois, United States
Albany Medical College
Albany, New York, United States
The Pennsylvania State University at The Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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IRB21-1952
Identifier Type: -
Identifier Source: org_study_id
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