RECRUITING

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

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Conditions

Elevated Serum PSAPSA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-08-01
Study Completion:2025-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05512754

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Normal digital rectal examination.
  3. * No clinical symptoms concerning acute urinary tract infection (e.g. dysuria, malodorous urine, positive urine culture)
  1. * Active urinary tract infections or bacteriuria
  2. * Known prostate cancer
  3. * Urethral catheter within the last 6 weeks
  4. * History of hypersensitivity or allergy to ibuprofen or NSAIDs.
  5. * Known severe chronic kidney disease: eGFR \< 30 mL/min/1.73 m2
  6. * Known history of severe liver disease (elevated AST or ALT greater than 3 times upper limit of normal)
  7. * History of gastrointestinal bleeding or NSAIDs induced GI adverse events
  8. * Concomitant dual-antiplatelet use or anticoagulants
  9. * Concomitant anti-inflammatory or steroidal drugs
  10. * Known bleeding disorder(s)
  11. * Patients with a solitary kidney or history of a kidney transplant
  12. * Any other medical contraindication to NSAIDs

Contacts and Locations

Study Contact

Matthew Ho, MD
CONTACT
17083058691
matthew.ho@uchospitals.edu

Principal Investigator

Scott Eggener, MD
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

University of Chicago
Chicago, Illinois, 60637
United States
Albany Medical College
Albany, New York, 12208
United States
The Pennsylvania State University at The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Scott Eggener, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-01
Study Completion Date2025-08-01

Study Record Updates

Study Start Date2022-08-01
Study Completion Date2025-08-01

Terms related to this study

Keywords Provided by Researchers

  • PSA

Additional Relevant MeSH Terms

  • Elevated Serum PSA