Overview
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.
Description
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.
V. Determine if vitamin D replacement is associated with improvement in progression free survival (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.
- 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.
Eligibility
Inclusion Criteria:
- 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
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