The Effect of IBD Flares on Serum PSA

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03558048
• Other study ID #: STU00207583
• Status: Recruiting
• Start date: August 1, 2019
• Est. completion date: October 1, 2025

Study information

• Verified date: April 2024
• Source: Northwestern University
• Contact: Shilajit Kundu, MD
• Phone: 312-695-8146
• Email: shilajit.kundu[@]nm.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 69 Years

Eligibility

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)

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Prostate Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between IBD and PSA	Measure PSA values in men with IBD before, during, and following a flare	12 months
Secondary	Location of disease	Analyze and correlate PSA increase with location of disease	12 months