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Recruiting NCT05045066

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

Early Phase I Interventional Localized Prostate Carcinoma Stage IV Prostate Cancer AJCC v8 Locally Recurrent Prostate Carcinoma Metastatic Prostate Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cholecalciferol, Quality-of-Life Assessment, Biospecimen Collection.
Who it may be relevant to
Registry conditions: Localized Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Locally Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Dietary supplement Cholecalciferol
    Given PO
  • Other Quality-of-Life Assessment
    Ancillary studies
  • Procedure Biospecimen Collection
    Undergo blood sample collection

Primary outcome measures

  • Change in circulating immunological cell function [Time frame: Baseline; 8 weeks]
Secondary outcome measures (3)
  • Prevalence of vitamin D insufficiency [Time frame: Baseline; 8 weeks]
  • Differences in the peripheral blood immunological cell function [Time frame: Baseline; 8 weeks]
  • Vitamin D replacement association with PSA progression free survival (PSA-PFS) [Time frame: Up to 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Mayo Clinic in Arizona — Scottsdale
  • Mayo Clinic in Florida — Jacksonville

Identifiers

NCT: NCT05045066 · MC210501 · HT94252411104 · PC230672P11 · 21-004555

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗