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.
African American males, age >= 18 years
Patients with a previous history of localized or metastatic or locally recurrent prostate cancer
Patients with Vitamin D levels below 30 ng/ml
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
Single group
Cholecalciferol
Dietary supplementGiven PO
Quality-of-Life Assessment
Other interventionAncillary studies
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
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.
Prevalence of vitamin D insufficiency
Participants will have blood drawn to measure serum levels of 25OHD. 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).
Differences in the peripheral blood immunological cell function
Levels of antigen-specific T cells and antibodies before and after vitamin D supplementation will be compared between black/AA patients with metastatic or locally recurrent prostate cancer and those with localized prostate cancer
Vitamin D replacement association with PSA progression free survival (PSA-PFS)
Participants with detectable changes in immune response will be compared to those with no detectable changes in immune response and compared to stage-matched historical controls to determine whether vitamin D replacement is associated with improvement in PFA-PFS.
Change in Quality of Life
Assessed by the Human Services' Centers for Disease Control and Prevention (CDC) Health-Related Quality of Life (HRQOL) Healthy Days Questionnaire. The questionnaire consists of 144 questions about an individual's self-rated general health over the past 30 days. Questions ask about the number of days for which mental and physical health was not good (# of days, none, or don't know/not sure) and whether poor mental or physical health days affected usual activities (yes, no, or don't know/not sure). A higher score (more healthy days) reflects better physical and mental well-being, while a lower score (more unhealthy days) indicates a greater impact from poor physical or mental health and activity limitations.
Difference in peripheral blood immunological cell function by population
A similar parallel study is being conducted at the University of Ilorin in Ilorin, Nigeria. Immunological results from the study at Mayo Clinic will be compared retrospectively with the results from the study in Nigeria under a separate study protocol.
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
