Prostate Cancer Clinical Trial
Differences in Immunological Effects of Vitamin D Replacement Among African American Prostate Cancer Patients With Localized Versus Metastatic Disease
Summary
This early phase I is to find out how common vitamin D deficiency 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 deficiency 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 deficiency which in several studies had been found to contribute to more aggressive prostate cancers.
Full Description
PRIMARY OBJECTIVES:
I. Determine the prevalence of vitamin D deficiency among African American (AA) prostate cancer patients.
II. Determine the changes in circulating immunological cell function among patients with vitamin D deficiency 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.
Eligibility Criteria
Inclusion Criteria:
African American males, age >= 18 years
Patients with a previous history of localized or metastatic prostate cancer
Patient willing to participate in the study and provide informed consent
Exclusion Criteria:
Known hypersensitivity to vitamin D
Chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection
End stage renal failure on dialysis
Liver cirrhosis
History of hypercalcemia
Legal inability or restricted legal ability. Medical or psychological conditions not allowing proper study completion or informed consent signature
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