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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. OUTLINE: Patients with low vitamin D3 levels receive cholecalciferol orally (PO) daily for 8 weeks in the absence of unacceptable toxicity.

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

Conditions
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Localized Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8

Intervention / Treatment
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* Dietary Supplement: Cholecalciferol
* Other: Quality-of-Life Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: African American males, age >= 18 years Patients with a previous history of localized or metastatic or locally recurrent 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 daily for the past month 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (cholecalciferol)<br>Patients with low vitamin D3 levels receive cholecalciferol PO daily for 8 weeks in the absence of unacceptable toxicity. | Dietary Supplement: Cholecalciferol<br>* Given PO<br>* Other names: Vitamin D3;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of vitamin D replacement on the peripheral blood cells' immunological function | Participants will have blood drawn at specified study timepoints to measure serum levels of 25-hydroxyvitamin D (25OHD) and determine immune response. Laboratory endpoints for 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. A patient will be considered to have responded if they had developed a ≥3-fold increase in antigen-specific T cells or antibodies at 8 weeks. If T-cell immunity was undetectable, a positive response was defined as ≥50 antigen-specific T cells/million PBMCs. | Up to 2 years | 
| Differences in peripheral blood immunological function among Black / African American (AA) patients with localized prostate cancer versus metastatic or locally recurrent prostate cancer | Participants will have blood drawn at specified study timepoints to measure serum levels of 25-hydroxyvitamin D (25OHD) and determine immune response. Unpaired data comparing the levels of immunity between patient groups will be done using the Mann-Whitney two-tailed test. Laboratory endpoints for 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. A patient will be considered to have responded if they had developed a ≥3-fold increase in antigen-specific T cells or antibodies at 8 weeks. If T-cell immunity was undetectable, a positive response was defined as ≥50 antigen-specific T cells/million peripheral blood mononuclear cells (PBMCs). | Up to 2 years | 
| Levels of antigen-specific T cells and antibodies | 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. | Up to 2 years | 
| Prevalence of vitamin D insufficiency among Black/AA patients with prostate cancer | Serum levels of 25-hydroxyvitamin D (25OHD) in the blood will be measured, and the mean and median 25OHD level will be estimated, as well as the percentage of participants that have low vitamin D levels (<30 ng/mL). | Up to 2 years | 
| Acceptability of vitamin D replacement therapy among Black/AA patients with prostate cancer | Acceptability will be assessed based based on interest on the study (percentage who agree to participate). | Up to 8 weeks |