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

Stage IV Prostate Cancer AJCC v8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05045066
• Other study ID #: MC210501
• Secondary ID: NCI-2021-0898721
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 29, 2021
• Est. completion date: August 31, 2026

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Stage IV Prostate Cancer AJCC v8

Intervention

Dietary Supplement:
• Cholecalciferol
Given PO

Other:
• Quality-of-Life Assessment
Ancillary studies

Procedure:
• Biospecimen Collection
Undergo blood sample collection

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of vitamin D replacement on the peripheral blood cells' immunological function	Participants will have blood drawn at specified study timepoints to measure serum levels of 25-hydroxyvitamin D (25OHD) and determine immune response. Laboratory endpoints for the levels of antigen-specific T cells and antibodies before and after vitamin D supplementation will be compared using either the Wilcoxon matched pairs two-tailed test or the Friedman test followed by post hoc Dunn Multiple Comparison's Test. A patient will be considered to have responded if they had developed a =3-fold increase in antigen-specific T cells or antibodies at 8 weeks. If T-cell immunity was undetectable, a positive response was defined as =50 antigen-specific T cells/million PBMCs.	Up to 2 years
Primary	Differences in peripheral blood immunological function among Black / African American (AA) patients with localized prostate cancer versus metastatic or locally recurrent prostate cancer	Participants will have blood drawn at specified study timepoints to measure serum levels of 25-hydroxyvitamin D (25OHD) and determine immune response. Unpaired data comparing the levels of immunity between patient groups will be done using the Mann-Whitney two-tailed test. Laboratory endpoints for the levels of antigen-specific T cells and antibodies before and after vitamin D supplementation will be compared using either the Wilcoxon matched pairs two-tailed test or the Friedman test followed by post hoc Dunn Multiple Comparison's Test. A patient will be considered to have responded if they had developed a =3-fold increase in antigen-specific T cells or antibodies at 8 weeks. If T-cell immunity was undetectable, a positive response was defined as =50 antigen-specific T cells/million peripheral blood mononuclear cells (PBMCs).	Up to 2 years
Primary	Levels of antigen-specific T cells and antibodies	The levels of antigen-specific T cells and antibodies before and after vitamin D supplementation will be compared using either the Wilcoxon matched pairs two-tailed test or the Friedman test followed by post hoc Dunn Multiple Comparison's Test. Unpaired data comparing the levels of immunity between patient groups will be done using the Mann-Whitney two-tailed test.	Up to 2 years
Primary	Prevalence of vitamin D insufficiency among Black/AA patients with prostate cancer	Serum levels of 25-hydroxyvitamin D (25OHD) in the blood will be measured, and the mean and median 25OHD level will be estimated, as well as the percentage of participants that have low vitamin D levels (<30 ng/mL).	Up to 2 years
Primary	Acceptability of vitamin D replacement therapy among Black/AA patients with prostate cancer	Acceptability will be assessed based based on interest on the study (percentage who agree to participate).	Up to 8 weeks
Primary	Progression free survival (PFS)	Participants with detectable changes in immune response will be compared to those with no detectable changes in immune response and compared to stage-matched historical controls to determine whether vitamin D replacement is associated with improvement in PFS.	Up to 2 years