The Effect of IBD Flares on Serum PSA

Recruiting

• Conditions: Inflammatory Bowel Diseases; Prostate Cancer
• Interventions: Diagnostic Test: Blood draw

• Registration Number: NCT03558048
• Lead Sponsor: Northwestern University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-06-05
• Study First Posted: 2018-06-15
• Study Start: 2019-08-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 400

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Men with Inflammatory Bowel Disease	Blood draw	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.

Primary Outcome Measures

Name	Time	Method
Relationship between IBD and PSA	12 months	Measure PSA values in men with IBD before, during, and following a flare

Secondary Outcome Measures

Name	Time	Method
Location of disease	12 months	Analyze and correlate PSA increase with location of disease

Trial Locations

Locations (1)

Northwestern Medicine; 🇺🇸 Chicago, Illinois, United States