NCT00058266终止2 期
A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 10
- 主要终点
- Decrease in prostate-specific antigen-positive cells
研究概览
简要总结
RATIONALE: Genistein may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase II trial to study the effectiveness of genistein in treating patients with localized prostate cancer who are planning to undergo radical prostatectomy.
详细描述
OBJECTIVES:
- Determine the toxicity of genistein in patients with localized prostate cancer treated with radical prostatectomy.
- Determine the decrease, if any, of prostate-specific antigen-positive cells in the operative field of patients treated with this drug.
- Determine the quality of life of patients treated with this drug.
OUTLINE: Patients receive 1 of 2 treatment regimens.
- Group A: Patients receive oral genistein once daily for 1-2 months, undergo radical prostatectomy, and then continue oral genistein once daily for 1-2 months afterward (for a total of 3 months of therapy).
- Group B: Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months.
Quality of life is assessed at baseline and at 1 and 3 months after surgery.
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
Decrease in prostate-specific antigen-positive cells
时间窗: At time of surgery
Alteration in cell morphology
时间窗: At time of surgery
Toxicity
时间窗: At surgery & monthly thereafter during treatment (3 mos)
次要结局
未报告次要终点
研究者
研究点 (10)
Loading locations...
相似试验
终止
2 期
Genistein in Treating Patients With Prostate CancerAdenocarcinoma of the ProstateRecurrent Prostate CancerStage I Prostate CancerStage II Prostate CancerStage III Prostate CancerNCT01126879Northwestern University12
已完成
早期 1 期
Genistein and Interleukin-2 in Treating Patients With Metastatic Melanoma or Kidney CancerKidney CancerMelanoma (Skin)NCT00276835Northwestern University15
撤回
2 期
Genistein in Treating Patients With Pancreatic Cancer That Can Be Removed by SurgeryPancreatic CancerNCT00882765Jonsson Comprehensive Cancer Center
Unknown
2 期
Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung CancerLung CancerNCT00616499Yonsei University35
已完成
2 期
Lapatinib Ditosylate in Treating Patients With Unresectable Liver or Biliary Tract CancerAdult Primary Hepatocellular CarcinomaAdvanced Adult Primary Liver CancerLocalized Unresectable Adult Primary Liver CancerRecurrent Adult Primary Liver CancerRecurrent Extrahepatic Bile Duct CancerRecurrent Gallbladder CancerUnresectable Extrahepatic Bile Duct CancerUnresectable Gallbladder CancerNCT00107536National Cancer Institute (NCI)26