NCT01379742Unknown4 期
Comparison of Health Related Quality of Life and Other Clinical Parameters Between ThinSeed™ and OncoSeed™ for Permanent Low Dose Rate Implantation in Localized Prostate Cancer
Prostate Cancer Foundation of Chicago2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2010年4月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Health related quality of life including urinary, bowel and sexual function as measured by the EPIC questionnaire
研究概览
简要总结
This study will investigate health related quality of life factors in patients undergoing low dose rate prostate brachytherapy. Patients will be randomized to Iodine-125 Thinstrand (for use with 20 g needles) or Rapidstrand (for use with standard 18 g needles). Urinary, bowel, sexual function and bother will be measured by the EPIC questionnaire at various time intervals.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate, clinical stage T1c - T2b, N0, M0
- •Greater than or equal to 40 years of age
- •Low and Low- Intermediate Risk prostate cancer
- •Prostate volumes by TRUS ≤ 60 cc
- •I-PSS score < 25 (alpha blockers allowed)
- •Signed study-specific informed consent form prior to study entry
排除标准
- •Lymph node involvement (N1)
- •Evidence of distant metastases (M1)
- •Radical surgery for carcinoma of the prostate
- •Prior pelvic radiation
- •Major medical or psychiatric illness, which in the investigator's opinion would prevent completion of treatment and would interfere with follow- up or ability to complete questionnaires
- •Hip prosthesis
- •Inability or refusal to provide informed consent
- •Evidence of Previous TURP
- •Prior hormone therapy
- •Prior TURP
结局指标
主要结局
Health related quality of life including urinary, bowel and sexual function as measured by the EPIC questionnaire
时间窗: 1 year
Randomized
次要结局
未报告次要终点
研究者
研究点 (2)
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