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Differences in Immunological Effects of Vitamin D Replacement among African American Prostate Cancer Patients with Localized versus Metastatic Disease
Trial Status: active
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.
Inclusion Criteria
PRE-REGISTRATION: African American males, age >= 18 years
PRE-REGISTRATION: Patients with a previous history of localized or metastatic or locally recurrent prostate cancer
REGISTRATION: Patients with Vitamin D levels below 30 ng/mL
Exclusion Criteria
PRE-REGISTRATION: Known hypersensitivity to vitamin D
PRE-REGISTRATION: End stage renal failure on dialysis
PRE-REGISTRATION: Liver cirrhosis
PRE-REGISTRATION: Currently taking a vitamin D or multivitamin supplement, that has more than 400 IU/10mcg of vitamin D daily for the past month
PRE-REGISTRATION: Legal inability or restricted legal ability, medical or psychological conditions not allowing proper study completion or informed consent signature
PRE-REGISTRATION: History of hypercalcemia
REGISTRATION: Chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection
Additional locations may be listed on ClinicalTrials.gov for NCT05045066.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Temporarily closed to accrual
Contact: Cassandra Nicole Moore
Phone: 480-301-8000
Florida
Jacksonville
Mayo Clinic in Florida
Status: Active
Contact: Gerardo Colon-Otero
Phone: 904-953-2693
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.
