RECRUITING

Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test

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

Prostate cancer is the most frequently diagnosed cancer in men in the Unites States. Nearly 1 million prostate biopsy procedures are performed in the United States annually and elevated prostate-specific antigen (PSA) level is the primary reason for prostate biopsy in \> 90% of cases. However, at the PSA levels which trigger prostate biopsy, often no cancer is found in prostate biopsy specimens. PSA test can be elevated due to reasons other than cancer such as inflammation or natural variation in the level. Investigators plan to treat men with elevated PSA level with over the counter anti-inflammatory medications (ibuprofen, naproxen) to see if the PSA level will decrease to an acceptable level.

Official Title

Effect of Non-steroidal Anti-inflammatory Drugs on Serum Prostate Specific Antigen Level

Quick Facts

Study Start:2022-09-27
Study Completion:2026-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05629494

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 within the past two years. A documented normal digital rectal examination by another physician or advanced practice provider (NP, PA, etc) is acceptable.
  3. * No clinical symptoms concerning for acute urinary tract infection (e.g. dysuria, malodorous urine, positive urine culture)
  1. * History of hypersensitivity or allergy to ibuprofen or NSAIDs.
  2. * History of peptic ulcer disease, GI bleeding or NSAIDs induced GI adverse events
  3. * Known bleeding disorders
  4. * Known severe chronic kidney disease: eGFR \< 30 mL/min/1.73 m2
  5. * Heart failure, significant heart disease
  6. * Poorly controlled hypertension
  7. * Active urinary tract infections or bacteriuria
  8. * Concomitant use of 5-alpha reductase inhibitors (finasteride, dutasteride) unless patient has been taking it for at least 6 months
  9. * Known prostate cancer or underwent prostate MRI or biopsy in the last year
  10. * Urinary tract instrumentation in the past 6 weeks (catheter, cystoscopy)
  11. * Concomitant anti-inflammatory or steroidal drugs
  12. * Concomitant dual-antiplatelet or anticoagulant therapy use except aspirin 81 mg alone
  13. * Know history of severe liver disease determined by abnormal liver function tests (elevated AST or ALT \> 3X ULN based on exiting history or labs)
  14. * Any other medical contraindication to NSAIDs

Contacts and Locations

Study Contact

Brenda Romeo
CONTACT
518-262-8579
amcurologyresearch@amc.edu

Principal Investigator

Badar Mian, MD
PRINCIPAL_INVESTIGATOR
Albany Medical College
Jay Raman, MD
PRINCIPAL_INVESTIGATOR
Penn State Health
Scott Eggener, MD
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Albany Medical Center
Albany, New York, 12208
United States
Penn State-Hershey Medical Center
Hershey, Pennsylvania, 17033
United States

Collaborators and Investigators

Sponsor: Albany Medical College

  • Badar Mian, MD, PRINCIPAL_INVESTIGATOR, Albany Medical College
  • Jay Raman, MD, PRINCIPAL_INVESTIGATOR, Penn State Health
  • 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 Date2022-09-27
Study Completion Date2026-12-01

Study Record Updates

Study Start Date2022-09-27
Study Completion Date2026-12-01

Terms related to this study

Keywords Provided by Researchers

  • Prostate-specific antigen
  • PSA test
  • Prostate biopsy
  • non-steroidal anti-inflammatory drugs NSAIDS

Additional Relevant MeSH Terms

  • Prostate Cancer
  • Prostate Inflammation
  • PSA