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

Mayo Clinic

Status and phase: Enrolling; Early Phase 1

Conditions: Stage IV Prostate Cancer AJCC v8; Locally Recurrent Prostate Carcinoma; Localized Prostate Carcinoma; Metastatic Prostate Carcinoma

Treatments: Other: Quality-of-Life Assessment; Dietary Supplement: Cholecalciferol; Procedure: Biospecimen Collection

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05045066

HT94252411104 (Other Grant/Funding Number)

NCI-2021-08987 (Registry Identifier)

MC210501 (Other Identifier)

PC230672P11 (Other Grant/Funding Number)

21-004555 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Treatment (cholecalciferol)

Experimental group

Description:

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:

Procedure: Biospecimen Collection

Dietary Supplement: Cholecalciferol

Other: Quality-of-Life Assessment