MC210501 Differences in Immunological Effects of Vitamin D Replacement Among Black/ African American (AA) Prostate Cancer Patients With Localized Versus Metastatic Disease
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.
Detailed description
PRIMARY OBJECTIVE: I. Determine the changes in circulating immunological cell function among patients with vitamin D insufficiency and the effects of vitamin D replacement on those changes. SECONDARY OBJECTIVES: I. Determine the prevalence of vitamin D insufficiency among black / African American (AA) prostate cancer patients. II. 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. III. Determine if vitamin D replacement is associated with improvement in prostate-specific antigen (PSA) progression free survival (PSA-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. CORRELATIVE OBJECTIVE: I. Determine if there are differences in the peripheral blood immunological cell function in Black/AA patients compared to West African/Black patients from Nigeria. 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. After completion of study treatment, patients are followed up at 56 days and then annually for 3 years.
Arms & interventions
- Dietary SupplementCholecalciferol
Given PO
- OtherQuality-of-Life Assessment
Ancillary studies
- ProcedureBiospecimen Collection
Undergo blood sample collection
Outcome measures
Primary
Change in circulating immunological cell function
Participants will have blood drawn to measure serum levels of 25-hydroxyvitamin D (25OHD) and to determine immune response. Laboratory endpoints for the levels of antigen-specific T cells and antibodies before and after vitamin D supplementation will be compared. A participant will be considered to have responded if they have developed a ≥3-fold increase in antigen-specific T cells or antibodies at 8 weeks. If T-cell immunity is undetectable, a positive response will be defined as ≥50 antigen-specific T cells/million PBMCs.
Time frame: Baseline; 8 weeks
Secondary
Prevalence of vitamin D insufficiency
Time frame: Baseline; 8 weeks
Differences in the peripheral blood immunological cell function
Time frame: Baseline; 8 weeks
Vitamin D replacement association with PSA progression free survival (PSA-PFS)
Time frame: Up to 3 years
Eligibility criteria
Study locations (2)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980