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

Early Phase 1

Recruiting

• Conditions: Localized Prostate Carcinoma; Stage IV Prostate Cancer AJCC v8
• Interventions: Dietary Supplement: Cholecalciferol; Other: Quality-of-Life Assessment; Procedure: Biospecimen Collection

• Registration Number: NCT05045066
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-16
• Study Start: 2021-12-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-09
• Primary Completion: 2025-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 400

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (cholecalciferol)	Cholecalciferol	Patients with low vitamin D3 levels receive cholecalciferol PO daily for 8 weeks in the absence of unacceptable toxicity. Patients undergo blood sample collection throughout the study.
Treatment (cholecalciferol)	Biospecimen Collection	Patients with low vitamin D3 levels receive cholecalciferol PO daily for 8 weeks in the absence of unacceptable toxicity. Patients undergo blood sample collection throughout the study.
Treatment (cholecalciferol)	Quality-of-Life Assessment	Patients with low vitamin D3 levels receive cholecalciferol PO daily for 8 weeks in the absence of unacceptable toxicity. Patients undergo blood sample collection throughout the study.

Primary Outcome Measures

Name	Time	Method
Acceptability of vitamin D replacement therapy among Black/AA patients with prostate cancer	Up to 8 weeks	Acceptability will be assessed based based on interest on the study (percentage who agree to participate).
Effects of vitamin D replacement on the peripheral blood cells' immunological function	Up to 2 years	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.
Prevalence of vitamin D insufficiency among Black/AA patients with prostate cancer	Up to 2 years	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).
Levels of antigen-specific T cells and antibodies	Up to 2 years	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.
Differences in peripheral blood immunological function among Black / African American (AA) patients with localized prostate cancer versus metastatic or locally recurrent prostate cancer	Up to 2 years	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).
Progression free survival (PFS)	Up to 2 years	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.

Trial Locations

Locations (2)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States