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The Effect of IBD Flares on Serum PSA

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03558048
Enrollment
400
Registered
2018-06-15
Start date
2019-08-01
Completion date
2025-10-01
Last updated
2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases, Prostate Cancer

Keywords

Prostate Specific Antigen, IBD, PSA

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTBlood 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.

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
40 Years to 69 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Relationship between IBD and PSA12 monthsMeasure PSA values in men with IBD before, during, and following a flare

Secondary

MeasureTime frameDescription
Location of disease12 monthsAnalyze and correlate PSA increase with location of disease

Countries

United States

Contacts

Primary ContactShilajit Kundu, MD
shilajit.kundu@nm.org312-695-8146
Backup ContactJazmine Stockdale, MS
urology@northwestern.edu312-694-2417

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026