Japanese Prostate Cancer Outcome Study by Permanent I-125 Seed Implantation [J-POPS]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,927
- 试验地点
- 31
- 主要终点
- PSA relapse-free survival
研究概览
简要总结
RATIONALE: Implant radiation therapy delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This clinical trial is studying the side effects and how well implant radiation therapy using radioactive iodine works in treating patients with localized prostate cancer.
详细描述
OBJECTIVES:
- To determine the efficacy of permanent brachytherapy with iodine I 125 seeds in patients with localized prostate cancer.
- To determine the safety of this therapy in these patients.
OUTLINE: This is a multicenter study.
Patients undergo permanent brachytherapy seed implantation comprised of iodine I 125 into the prostate. Some patients may receive combination treatment (e.g., external beam radiation therapy (EBRT) or hormone therapy in addition to brachytherapy).
Quality of life and the International Prostate Symptom Score (IPSS) is assessed and compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 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
PSA relapse-free survival
时间窗: 5 years
Defined as the duration from enrollment to the date of biological relapse, which was defined as three consecutive prostate specific antigen (PSA) rises in the reflex range of 1.0 ng/ml or greater, and the date of failure was the midpoint between the first day that showed PSA levels 1.0 ng/ml or greater and the last day in which the level was below 1.0 ng/ml.
次要结局
- Adverse events(36 months)
- Progression free survival (PFS)(5 years)
- Quality of life(Baseline, Month 3, 12, 24 and 36)
- IPSS score(Baseline, Month 3, 12, 24 and 36)