Early phase 1Recruiting

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

MC210501 Differences in Immunological Effects of Vitamin D Replacement Among Black/ African American (AA) Prostate Cancer Patients With Localized Versus Metastatic Disease

Sponsor
Mayo Clinic (Academic or other)
Enrolment
220 planned
Conditions
Localized Prostate Carcinoma; Stage IV Prostate Cancer AJCC v8; Locally Recurrent Prostate Carcinoma; Metastatic Prostate Carcinoma
Interventions
Cholecalciferol; Quality-of-Life Assessment; Biospecimen Collection
Ages
adults, older adults
Registry
NCT05045066

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Change in circulating immunological cell function

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered