Differences in Immunological Effects of Vitamin D Replacement Among African American Prostate Cancer Patients With Localized Versus Metastatic Disease

Differences in Immunological Effects of Vitamin D Replacement Among African American Prostate Cancer Patients With Localized Versus Metastatic Disease

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

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.

PRIMARY OBJECTIVES: I. Determine the prevalence of vitamin D insufficiency among 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 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 AA patients with metastatic prostate cancer compared to those with localized prostate cancer. OUTLINE: Patients with low vitamin D3 levels receive cholecalciferol orally (PO) daily for 8 weeks in the absence of unacceptable toxicity.

Patients with low vitamin D3 levels receive cholecalciferol PO daily for 8 weeks in the absence of unacceptable toxicity.

Differences in peripheral blood immunological function among African American (AA) patients with localized prostate cancer versus metastatic prostate cancer

The levels of antigen-specific T cells and antibodies before and after vitamin D supplementation will be compared using either the Wilcoxon matched pairs two-tailed test or the Friedman test followed by post hoc Dunn Multiple Comparison's Test. Unpaired data comparing the levels of immunity between patient groups will be done using the Mann-Whitney two-tailed test.

Inclusion Criteria: African American males, age >= 18 years Patients with a previous history of localized or metastatic prostate cancer Willing to travel to Mayo Clinic for baseline and 8 weeks visit for blood collection, if eligible Patients with Vitamin D levels below 30 ng/mL Exclusion Criteria: Known hypersensitivity to vitamin D End stage renal failure on dialysis Liver cirrhosis Currently taking a vitamin D or multivitamin supplement, that has more than 400 IU/10mcg of vitamin D Legal inability or restricted legal ability. Medical or psychological conditions not allowing proper study completion or informed consent signature Chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection History of hypercalcemia