Phase 1 Study of Evaluation of Lithium and it's Effect on Clinically Localized Prostate Cancer.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Observe any change to Performance Status and Adverse Events related to Lithium
研究概览
简要总结
Laboratory testing has suggested that lithium may decrease the incidence of certain types of cancer, including prostate cancer. Additional research has suggested that lithium decreases prostate cancer tumor size over time. This study will investigate the effect of lithium on men with prostate cancer.
详细描述
As lithium has been shown in an in vitro model to suppress cellular proliferation, and suppress tumor growth in an in vivo xenograft model, we propose to determine its effect on prostate cancer cells in human patients undergoing radical prostatectomy. In this pilot study we plan to assess the toxicity of lithium administration in patients prior to radical prostatectomy. This will include any clinical toxicity as well as any increase in intra-, peri- or postoperative complications.
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
- •Ability to understand and the willingness to sign a written informed consent form.
- •Subjects with histologically confirmed local adenocarcinoma of the prostate who have elected to proceed with radical prostatectomy as primary curative therapy.
- •Subjects having no prior administration of lithium or lithium containing medications within 90 days of study enrollment.
- •Subjects >/= 18 years of age.
- •ECOG (Eastern Cooperative Oncology Group) performance status of </=
- •Adequate renal function defined as GFR (Glomerular Filtration Rate) >/= 50 mL/min.
- •Use of adequate contraception
- •ECG (Electrocardiogram) within normal limits.
- •Subjects must agree not to take any new vitamin supplements or herbal remedy during the study period.
- •Subjects must be able to safety take lithium carbonate for at least 4 weeks before scheduled prostatectomy.
排除标准
- •Subjects who have received any investigational medication within 30 days of first lithium dose.
- •Subjects currently receiving, or who have had previous hormonal, chemotherapy or radiotherapy for prostate cancer.
- •Subjects with known brain metastases.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to lithium carbonate.
- •Uncontrolled intercurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
Lithium
Oral lithium carbonate dose escalation: Level 1 of 600 mg/day, then escalating to Level 2 of 900 mg/day, then the final Level 3 of 1200 mg/day.
干预措施: Lithium Carbonate (Drug)
结局指标
主要结局
Observe any change to Performance Status and Adverse Events related to Lithium
时间窗: Weekly for 4 weeks prior to radical prostatectomy and continuing for 1 - 2 weeks after surgery
To determine the safety and tolerability of lithium in subjects with clinically localized prostate cancer.
次要结局
- Serum lithium levels(Weekly for up to 4 weeks prior to radical prostatectomy)