The Effect of IBD Flares on Serum PSA

Clinicaltrials.gov ID: NCT03558048
db-list-check Status RECRUITING
b-loader Phase
b-people Age 40 - 69 Years
b-bullseye-arrow Enrollments 400

Conditions

Inflammatory Bowel Diseases, Prostate Cancer

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • Jazmine Stockdale
  • 312-695-8146

Eligibility Criteria

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

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

    Description:

    Subjects will have their blood drawn during clinic visits over the course of the study period to measure their serum prostate specific antigen levels.

Outcome Measures

Primary Outcome Measures

Relationship between IBD and PSA

Time Frame: 12 months

Secondary Outcome Measures

Location of disease

Time Frame: 12 months

Timeline

  • Last Updated
    April 24, 2024
  • Start Date
    June 15, 2018
  • Today
    May 12, 2025
  • Completion Date ( Estimated )
    October 1, 2025

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