NCT02391051招募中2 期
Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial
University of Erlangen-Nürnberg Medical School2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Intensity and frequency of adverse events
研究概览
简要总结
This trial examines the feasibility and toxicity of focal brachytherapy in patients with low-risk prostate cancer.
详细描述
Patients with low-risk prostate cancer will receive HDR-Brachytherapy: 2 x 13,5 Gy.
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
- •Age > 18
- •Histologically confirmed prostate cancer
- •Gleason Score of index lesion ≤ 6 (3+3)
- •Tumor stage: cT1-2a cN0 cM0
- •Unilateral affection; index lesion ≤ 0.5ml with or without clinically non-significant lesion contralateral. No more than 25% of the punch should be affected. Therefore a 3D-TPM-biopsy is mandatory before treatment.
- •PSA ≤ 10/ng/ml
- •Prostate volume < 60 m^3
- •No distant metastasis
- •Life expectancy > 10 years
- •Informed consent
排除标准
- •Tumor stage ≥ T2b
- •Known metastasis: N+ and/or M1
- •General anesthesia or peridural anesthesia is not possible
- •Coagulation disorder
研究组 & 干预措施
Focal Brachytherapy
Experimental
HDR-Brachytherapy, 2 fractions within at least 24 but max. 30 hours, each 13,5 Gy
干预措施: HDR-Brachytherapy (Radiation)
结局指标
主要结局
Intensity and frequency of adverse events
时间窗: 6 weeks after therapy
次要结局
- Correlation of Markers RTEN, ERG, APN, Ki67, KPNA1, PSMA, FGFR1, PMP22, CDKN1A/P16, PDCD4, KLF6, PITX with PSA free survival(10 years after therapy)
- Correlation of microRNA141 and -375 with outcome(10 years after therapy)
- Feasibility, as measured by NCI-CTCAE-scale, EORTC-QLQ, IIEF, IPSS, ICIQ(6 weeks after therapy)
- Tumor regression(6 weeks up to 10 years after therapy)
- Rate of recurrences measured by PSA(10 years after therapy)
研究者
研究点 (2)
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