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Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients

Stage IV Prostate Cancer AJCC v8 Clinical Trial

Official title:
Differences in Immunological Effects of Vitamin D Replacement Among Black/African American (AA) Prostate Cancer Patients With Localized Versus Metastatic Disease

Clinical Trial Summary

This early phase I is to find out how common vitamin D insufficiency is among African American patients with a history of prostate cancer that has not spread to other parts of the body (localized) or has spread to other places in the body (metastatic) and how vitamin D insufficiency affects the immune system. This study also aims to find out if replacing vitamin D results in normalization of the immune function. Information from this study may benefit prostate cancer patients by identifying vitamin D insufficiency which in several studies had been found to contribute to more aggressive prostate cancers.

Clinical Trial Description

PRIMARY OBJECTIVES: I. Determine the prevalence of vitamin D insufficiency among black / African American (AA) prostate cancer patients. II. Determine the changes in circulating immunological cell function among patients with vitamin D insufficiency and the effects of vitamin D replacement on those changes. III. Determine the acceptability of cholecalciferol (vitamin D) replacement therapy among black / AA prostate cancer patients and potential impact on health-related quality of life. IV. Determine if there are differences in the peripheral blood immunological cell function in black / AA patients with metastatic or locally recurrent prostate cancer compared to those with localized prostate cancer. V. Determine if vitamin D replacement is associated with improvement in progression free survival (PFS) of black/AA patients with prostate cancer with detectable changes in immune response compared to those with no detectable changes in immune response and compared to stage matched historical controls. OUTLINE: Patients with low vitamin D3 levels receive cholecalciferol orally (PO) daily for 8 weeks in the absence of unacceptable toxicity. Patients undergo blood sample collection throughout the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05045066
Study type Interventional
Source Mayo Clinic
Contact
Status Recruiting
Phase Early Phase 1
Start date December 29, 2021
Completion date August 31, 2026
View Details
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