Spots Global Cancer Trial Database for Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients

Official Title: Differences in Immunological Effects of Vitamin D Replacement Among Black/African American (AA) Prostate Cancer Patients With Localized Versus Metastatic Disease

Study ID: NCT05045066

Conditions

Localized Prostate Carcinoma

Stage IV Prostate Cancer AJCC v8

Interventions

Cholecalciferol

Quality-of-Life Assessment

Biospecimen Collection

Study Description

Brief Summary: 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.

Detailed 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.