The Effect of IBD Flares on Serum PSA

The Effect of Inflammatory Bowel Disease Flares on Serum Prostate Specific Antigen

This study will measure Prostate Specific Antigen (PSA) values in men with Inflammatory Bowel Disease (IBD) before, during, and following a flare. In addition, the effect of any PSA increase will be analyzed and correlated to the location of disease (rectal vs. other). Study findings may help men with IBD by identifying pitfalls in prostate cancer screening for this population and help to stratify and understand the effect IBD has on the prostatic milieu. By optimizing how men with IBD are screened for prostate cancer, future unnecessary healthcare encounters and expenditures may be reduced for this patient group.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Prostate Cancer
• Intervention / Treatment: Diagnostic test: Blood draw

Detailed Description

Over one million adults in the U.S. are estimated to suffer from Inflammatory Bowel Disease (IBD), accounting for more than 2 million ambulatory and emergency room visits annually. This healthcare utilization may lead to an average increase of $5,000-$8,000 in annual medical expenditure per patient. Reducing unnecessary medical interactions and expenditures in this patient group is paramount and requires individualized disease monitoring and healthcare screening

One screening test that may lead to additional exams and costs is the Prostate Specific Antigen (PSA) test used to screen for prostate cancer. While PSA screening can reduce prostate cancer mortality, false-positive elevations are common, especially in the setting of non-malignant prostate inflammation. This research group recently reported in a large retrospective case-control series that after age 65, men with IBD who underwent prostate cancer screening at Northwestern Memorial Hospital (NMH) had higher serum PSA values than non-IBD controls. In addition, men with IBD had a significantly higher risk of clinically significant prostate cancer even when controlling for differences in PSA and other relevant covariates. However, whether the elevation in PSA is related to inflammation in these men with IBD versus a true reflection of an increased risk of prostate cancer is unclear. Furthermore, the interplay of IBD status and screening PSA values is currently unknown.

This study will measure PSA values in men with IBD before, during, and following a flare. In addition, the effect of any PSA increase will be analyzed and correlated to the location of disease (rectal vs. other). Study findings may help men with IBD by identifying pitfalls in prostate cancer screening for this population and help to stratify and understand the effect IBD has on the prostatic milieu. By optimizing how men with IBD are screened for prostate cancer, future unnecessary healthcare encounters and expenditures may be reduced for this patient group.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Shilajit Kundu, MD; Phone Number: 312-695-8146; Email: shilajit.kundu@nm.org
• Study Contact Backup: Name: Jazmine Stockdale, MS; Phone Number: 312-694-2417; Email: urology@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Medicine
      • Contact: Jazmine Stockdale; Phone Number: 312-695-8146

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will include men ages 40 to 69 presenting to the Northwestern Memorial Hospital Gastroenterology Clinic with a diagnosis of IBD. Men with a history of prostate cancer or prior prostate procedures (transurethral resection or biopsies) will be excluded.

Description

Inclusion Criteria:

• Men, ages 40-69 years old
• Confirmed diagnosis of IBD presenting to the Northwestern Memorial Hospital Gastroenterology Clinic

Exclusion Criteria:

• History of prostate cancer or prior prostate procedures (biopsies or transurethral resection)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Men with Inflammatory Bowel Disease; Men with a confirmed diagnosis of IBD between the ages of 40-69 years old. These subjects will have their prostate specific antigen checked via a blood draw during clinic visits over the course of the study period.	Diagnostic test: Blood draw; Subjects will have their blood drawn during clinic visits over the course of the study period to measure their serum prostate specific antigen levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between IBD and PSA	Measure PSA values in men with IBD before, during, and following a flare	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Location of disease	Analyze and correlate PSA increase with location of disease	12 months

Collaborators and Investigators

• Sponsor: Northwestern University

Publications and helpful links

General Publications

• Kappelman MD, Moore KR, Allen JK, Cook SF. Recent trends in the prevalence of Crohn's disease and ulcerative colitis in a commercially insured US population. Dig Dis Sci. 2013 Feb;58(2):519-25. doi: 10.1007/s10620-012-2371-5. Epub 2012 Aug 29.
• Ananthakrishnan AN, McGinley EL, Saeian K, Binion DG. Trends in ambulatory and emergency room visits for inflammatory bowel diseases in the United States: 1994-2005. Am J Gastroenterol. 2010 Feb;105(2):363-70. doi: 10.1038/ajg.2009.580. Epub 2009 Oct 6.
• Kappelman MD, Rifas-Shiman SL, Porter CQ, Ollendorf DA, Sandler RS, Galanko JA, Finkelstein JA. Direct health care costs of Crohn's disease and ulcerative colitis in US children and adults. Gastroenterology. 2008 Dec;135(6):1907-13. doi: 10.1053/j.gastro.2008.09.012. Epub 2008 Sep 17.
• Oesterling JE, Jacobsen SJ, Chute CG, Guess HA, Girman CJ, Panser LA, Lieber MM. Serum prostate-specific antigen in a community-based population of healthy men. Establishment of age-specific reference ranges. JAMA. 1993 Aug 18;270(7):860-4.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: June 5, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: PSA; IBD; Prostate Specific Antigen
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: STU00207583

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans at this time to share individual participant data with other researchers. All patient identifying data will be removed prior to transfer to a statistician. No individual research subject will be identified in any reports from the study which will be statistical in nature.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No