Cell Kinetic Study of Bromodeoxyuridine (BrdU) in Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Average doubling time between low and high volume tumors
研究概览
简要总结
Phase II trial to study the effectiveness of broxuridine in treating patients who are undergoing surgery for stage I or stage II prostate cancer. Broxuridine may help doctors determine the rate of growth of prostate tumors and help them plan effective treatment
详细描述
OBJECTIVES:
I. Measure the potential doubling times of multifocal adenocarcinomas of the prostate using broxuridine.
II. Determine whether the doubling times of multifocal carcinomas occurring within a single prostate are consistent with a model in which low-volume carcinomas have slow doubling times and high-volume carcinomas have fast doubling times.
OUTLINE:
Patients receive broxuridine IV over 30 minutes on day -1. Approximately 12-96 hours later, patients undergo surgery to remove the prostate. Tumor tissue is examined by immunostaining for the presence of broxuridine to determine doubling times of the tumor.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stage I or II (T1-2) carcinoma of the prostate
- •PSA greater than 8 ng/mL
- •Abnormal findings on digital rectal examination
- •Eligible for radical prostatectomy
- •Performance status - ECOG 0 or 1
- •No prior biologic therapy
- •No prior chemotherapy
- •No prior neoadjuvant hormonal therapy
- •No prior radiotherapy
- •See Disease Characteristics
- •No prior therapy that would affect tumor growth rates or volume
排除标准
- 未提供
研究组 & 干预措施
Treatment (bromodeoxyuridine)
Patients receive broxuridine IV over 30 minutes on day -1. Approximately 12-96 hours later, patients undergo surgery to remove the prostate.Tumor tissue is examined by immunostaining for the presence of broxuridine to determine doubling times of the tumor.
干预措施: bromodeoxyuridine (Drug)
Treatment (bromodeoxyuridine)
Patients receive broxuridine IV over 30 minutes on day -1. Approximately 12-96 hours later, patients undergo surgery to remove the prostate.Tumor tissue is examined by immunostaining for the presence of broxuridine to determine doubling times of the tumor.
干预措施: conventional surgery (Procedure)
Treatment (bromodeoxyuridine)
Patients receive broxuridine IV over 30 minutes on day -1. Approximately 12-96 hours later, patients undergo surgery to remove the prostate.Tumor tissue is examined by immunostaining for the presence of broxuridine to determine doubling times of the tumor.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Average doubling time between low and high volume tumors
时间窗: Up to 3 years
次要结局
未报告次要终点