MC210501 Differences in Immunological Effects of Vitamin D Replacement Among Black/ African American (AA) Prostate Cancer Patients With Localized Versus Metastatic Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 220
- 试验地点
- 4
- 主要终点
- Change in circulating immunological cell function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment (cholecalciferol)
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.
干预措施: Cholecalciferol (Dietary Supplement)
Treatment (cholecalciferol)
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.
干预措施: Biospecimen Collection (Procedure)
Treatment (cholecalciferol)
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.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Change in circulating immunological cell function
时间窗: 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.
次要结局
- Prevalence of vitamin D insufficiency(Baseline; 8 weeks)
- Differences in the peripheral blood immunological cell function(Baseline; 8 weeks)
- Vitamin D replacement association with PSA progression free survival (PSA-PFS)(Up to 3 years)