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Идёт набор NCT05045066

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

Ранняя фаза I С лечением Localized Prostate Carcinoma Stage IV Prostate Cancer AJCC v8 Locally Recurrent Prostate Carcinoma Metastatic Prostate Carcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cholecalciferol, Quality-of-Life Assessment, Biospecimen Collection.
Кому может быть актуально
Состояния в реестре: Localized Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Locally Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Пищевая добавка Cholecalciferol
    Given PO
  • Другое Quality-of-Life Assessment
    Ancillary studies
  • Процедура Biospecimen Collection
    Undergo blood sample collection

Первичные конечные точки

  • Change in circulating immunological cell function [Срок оценки: Baseline; 8 weeks]
Вторичные конечные точки (3)
  • Prevalence of vitamin D insufficiency [Срок оценки: Baseline; 8 weeks]
  • Differences in the peripheral blood immunological cell function [Срок оценки: Baseline; 8 weeks]
  • Vitamin D replacement association with PSA progression free survival (PSA-PFS) [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Mayo Clinic in Arizona — Scottsdale
  • Mayo Clinic in Florida — Jacksonville

Идентификаторы

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗