Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-26 @ 5:55 AM
Study NCT ID:
NCT05045066
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2021-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Differences in Immunological Effects of Vitamin D Replacement Among Black/African American (AA) Prostate Cancer Patients With Localized Versus Metastatic Disease
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: