Prostate Cancer Clinical Trial
Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients
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 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 Criteria
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 2 Locations for this study
How clear is this clinincal trial information?