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; Locally Recurrent Prostate Carcinoma; Metastatic Prostate Carcinoma

• 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 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.

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: 2025-09
• Last Update Submitted: 2025-09-05
• Last Update Posted: 2025-09-12
• Primary Completion: 2026-08-31
• Study Completion: 2029-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

• Pre-Registration:

  • African American males, age >= 18 years
  • Patients with a previous history of localized or metastatic or locally recurrent prostate cancer

• Registration:

  • Patients with Vitamin D levels below 30 ng/ml

Exclusion Criteria

• Pre-Registration:

  • 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

• Registration:

  • Chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in circulating immunological cell function	Baseline; 8 weeks	Participants will have blood drawn to measure serum levels of 25-hydroxyvitamin D (25OHD) and to determine immune response. Laboratory endpoints for the levels of antigen-specific T cells and antibodies before and after vitamin D supplementation will be compared. A participant will be considered to have responded if they have developed a ≥3-fold increase in antigen-specific T cells or antibodies at 8 weeks. If T-cell immunity is undetectable, a positive response will be defined as ≥50 antigen-specific T cells/million PBMCs.

Secondary Outcome Measures

Name	Time	Method
Prevalence of vitamin D insufficiency	Baseline; 8 weeks	Participants will have blood drawn to measure serum levels of 25OHD. 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).
Differences in the peripheral blood immunological cell function	Baseline; 8 weeks	Levels of antigen-specific T cells and antibodies before and after vitamin D supplementation will be compared between black/AA patients with metastatic or locally recurrent prostate cancer and those with localized prostate cancer
Vitamin D replacement association with PSA progression free survival (PSA-PFS)	Up to 3 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 PFA-PFS.

Trial Locations

Locations (2)

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

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