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NCT Number: NCT05045066

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

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.

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Key information

Conditions

Localized Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Locally Recurrent Prostate Carcinoma Male Urogenital Diseases Metastatic Prostate Carcinoma Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Stage IV Prostate Cancer AJCC v8 Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Dietary Supplement

Given PO

Other names: 9,10-Secocholesta-5,7,10(19)-trien-3-ol, Calciol, Delsterol, Vitamin D3

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Primary outcomes

  1. Change in circulating immunological cell function

    Time frame: 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 outcomes

  1. Prevalence of vitamin D insufficiency

    Time frame: 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).

  2. Differences in the peripheral blood immunological cell function

    Time frame: 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

  3. Vitamin D replacement association with PSA progression free survival (PSA-PFS)

    Time frame: 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.

Other outcomes

  1. Change in Quality of Life

    Time frame: Baseline; 8 weeks

    Assessed by the Human Services' Centers for Disease Control and Prevention (CDC) Health-Related Quality of Life (HRQOL) Healthy Days Questionnaire. The questionnaire consists of 144 questions about an individual's self-rated general health over the past 30 days. Questions ask about the number of days for which mental and physical health was not good (# of days, none, or don't know/not sure) and whether poor mental or physical health days affected usual activities (yes, no, or don't know/not sure). A higher score (more healthy days) reflects better physical and mental well-being, while a lower score (more unhealthy days) indicates a greater impact from poor physical or mental health and activity limitations.

  2. Difference in peripheral blood immunological cell function by population

    Time frame: Up to 3 years

    A similar parallel study is being conducted at the University of Ilorin in Ilorin, Nigeria. Immunological results from the study at Mayo Clinic will be compared retrospectively with the results from the study in Nigeria under a separate study protocol.

Study contacts

Contact information is provided by the study sponsor or research team.

Cancer Center Clinical Trials

CONTACT

866-273-4681 or 507-266-4000

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Congressionally Directed Medical Research Programs

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2029
First posted
Sep 16, 2021
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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