A Pilot Feasibility Study of Sipuleucel-T vs. Sipuleucel-T and Low-protein Diet in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Adherence to diet intervention
研究概览
简要总结
This is a single-center, randomized, open-label study to assess the feasibility of a low-protein diet intervention in patients with metastatic castrate-resistant prostate cancer (CRPC) who are receiving treatment with sipuleucel-T. Subjects will be randomized (1:1 ratio) to either Arm 1 or Arm 2 (Fig. 1).
Arm 1: Subjects randomized to Arm 1 will be treated with sipuleucel-T infusion on Day 1, every two weeks for a total of three infusions. Subjects on this arm will receive a control diet containing 20% protein.
Arm 2: Subjects randomized to Arm 2 will be treated with sipuleucel-T infusion on Day 1, every two weeks for a total of three infusions. Subjects on this arm will receive a low-protein diet containing 10% protein.
Patients with metastatic, asymptomatic or minimally symptomatic CRPC that has progressed despite androgen deprivation therapy will be eligible for the study. After informed consent eligible patients will be scheduled to receive sipuleucel-T (three infusions two weeks apart) with normal-protein diet vs. low-protein diet. Each cycle will be every 14 days. Diet intervention will commence 1 week prior to the first apheresis (Day -7) and will continue until 10 days after the last infusion of sipuleucel-T (Day +42) (Fig. 2).
详细描述
Primary Objective To assess the feasibility of low-protein diet intervention in patients with metastatic CRPC receiving immunotherapy with sipuleucel-T. Change in blood urea nitrogen (BUN) and urine urea nitrogen (UUN) from baseline to 6 weeks will be measured to assess adherence of following the diet intervention. The expected changes (mean, standard deviation) in BUN are 5.5 ± 2.6 mg/dL with 10% protein diet arm and 2.5 ± 2.6 mg/dL with 20% protein diet arm (please see section 12.5.7).
Secondary Objectives
- To assess whether low-protein diet intervention augments the immune response to sipuleucel-T in men with metastatic CRPC.
- To assess the safety and tolerability of the combination of sipuleucel-T and low-protein diet intervention.
- To obtain preliminary evidence of clinical efficacy of the combination of sipuleucel-T and low-protein diet compared to sipuleucel-T and control-diet, including objective response rate (partial + complete response), progression-free survival (PFS) and overall survival (OS), and changes in prostate-specific antigen (PSA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Adherence to diet intervention
时间窗: 6 weeks
BUN and UUN laboratory values
次要结局
- Safety and tolerability of diet intervention combined with sipuleucel-T treatment(6 weeks)
- Overall survival(2 years)
- Rate of immune response(6, 12, and 14 weeks)
- Progression free survival(2 years)
- Feasibility of diet intervention(6 weeks)