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

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ClinicalTrials.gov Identifier: NCT05512754
Recruitment Status : Recruiting
First Posted : August 23, 2022
Last Update Posted : October 12, 2022
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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Brief Summary:
The purpose of this study is to assess the impact of ibuprofen in men with elevated serum PSA.

Condition or disease Intervention/treatment Phase
Elevated Serum PSA Drug: Ibuprofen 400 mg Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization into two groups between Group A (No NSAIDs) or Group B (Ibuprofen 400 mg q 8 h for 10 days)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Anti-inflammatory Medications in Patients With Elevated Serum Prostate-specific Antigen
Actual Study Start Date : August 1, 2022
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Advil
No Intervention: Control
Participants receive no NSAIDs


Outcome Measures
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Primary Outcome Measures :
  1. Change of serum PSA compared with baseline [ Time Frame: Baseline, 6 weeks ]
    serum prostatic specific antigen


Secondary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  • Any other medical contraindication to NSAIDs
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05512754


Contacts
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Contact: Matthew Ho, MD 17083058691 matthew.ho@uchospitals.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Matthew Ho, MD    708-305-8691    Matthew.Ho@uchospitals.edu   
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Scott Eggener, MD University of Chicago
More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT05512754    
Other Study ID Numbers: IRB21-1952
First Posted: August 23, 2022    Key Record Dates
Last Update Posted: October 12, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Chicago:
PSA
Additional relevant MeSH terms:
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Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action