Randomized Placebo-Controlled, Double-Blind Study of Cholecalciferol Replacement in Patients on Expectant Management for Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- PSA Response
研究概览
简要总结
This randomized clinical trial studies how well cholecalciferol supplement works in treating patients with localized prostate cancer undergoing observation. Cholecalciferol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly.
详细描述
PRIMARY OBJECTIVES:
I. To determine the prostate-specific antigen (PSA) response with oral high dose vitamin D3 supplementation (cholecalciferol) in patients with localized, histologically proven adenocarcinoma of the prostate who have not received any treatment for prostate cancer ever and have chosen expectant management.
SECONDARY OBJECTIVES:
I. To examine the pattern of response of PSA dynamics as well as the absolute change in PSA following vitamin D3 supplementation.
II. Assess the toxicity of vitamin D3 supplementation in men with prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Any patient with clinically localized, histologically proven adenocarcinoma of prostate who has not received any treatment for prostate cancer ever and has chosen active surveillance; treatment for prostate cancer is defined as prostatectomy, androgen deprivation, brachytherapy or a full course of external beam irradiation
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Willingness to comply with study guidelines
- •Willingness and ability to consent
- •25(OH) D3 level less than 40 ng/ml within 3 months of initiation of study; most recent 25 hydroxy D level within last 3 month would be used
排除标准
- •History of malabsorption syndrome e.g., pancreatic insufficiency, celiac disease, tropical sprue
- •Creatinine > 2.0 mg/dL
- •Corrected serum calcium level of > 10.5 mg/dL (serum corrected calcium = serum calcium + 0.8[4-serum albumin])
- •Most recent PSA value more than 18 months ago
- •Prior or current therapy for prostate cancer
- •Documented history of nephrolithiasis within the past 5 years
- •Patients receiving finasteride (Proscar) or dutasteride (Avodart) or men who have received either agent within 90 days of entry are ineligible
- •Patients cannot take any additional vitamin D supplementation during study treatment; patients taking > 2000 IU per day prior to treatment will be ineligible
研究组 & 干预措施
Arm I (cholecalciferol and placebo)
Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm II.
干预措施: Cholecalciferol (Dietary Supplement)
Arm I (cholecalciferol and placebo)
Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm II.
干预措施: Laboratory Biomarker Analysis (Other)
Arm I (cholecalciferol and placebo)
Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm II.
干预措施: Patient Observation (Other)
Arm I (cholecalciferol and placebo)
Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm II.
干预措施: Placebo Administration (Drug)
Arm I (cholecalciferol and placebo)
Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm II.
干预措施: Quality-of-Life Assessment (Other)
Arm I (cholecalciferol and placebo)
Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm II.
干预措施: Questionnaire Administration (Other)
Arm II (placebo and cholecalciferol)
Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm I.
干预措施: Cholecalciferol (Dietary Supplement)
Arm II (placebo and cholecalciferol)
Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm I.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (placebo and cholecalciferol)
Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm I.
干预措施: Patient Observation (Other)
Arm II (placebo and cholecalciferol)
Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm I.
干预措施: Placebo Administration (Drug)
Arm II (placebo and cholecalciferol)
Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm I.
干预措施: Quality-of-Life Assessment (Other)
Arm II (placebo and cholecalciferol)
Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm I.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
PSA Response
时间窗: 9 month period: pre-Vitamin D/pre-placebo to 9 months after start of vitamin D/ placebo, up to 30 days after completion of study treatment
Difference in the mean change in PSA on vitamin D (9 month period: pre-Vitamin D to 9 months after start of vitamin D) versus on placebo (9 month period: pre-Placebo to 9 months after starting placebo). Compared using a paired t-test.
次要结局
- Slope of PSA Concentration Over Time(9 month period: pre-Vitamin D/pre-placebo to 9 months after start of vitamin D/ placebo, up to 30 days after completion of study treatment -Up to 30 days after completion of study treatment)
- Toxicity as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0(Up to 30 days after completion of study treatment (up to 22 months from start of study).)