NCT02077335Unknown2 期
Phase II Study of High-dose Rate (HDR) Monotherapy for the Treatment of Low and Intermediate Risk Prostate Cancer
CSSS de Gatineau2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Disease-free survival
研究概览
简要总结
The purpose of this study is to determine the clinical efficacy and toxicity of High-dose rate (HDR) brachytherapy as monotherapy for the treatment of low risk and intermediate risk prostate cancer.
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
- •Biopsy proven Adenocarcinoma of the Prostate
- •Clinical stage T1c, T2a or T2b
- •PSA less than 20 ng/ml
- •Gleason Score 6 or 7
排除标准
- •Age less than 18 years
- •Clinical stage T2c, T3 ou T4
- •Clinical Stage N1
- •Clinical Stage M1
- •Prostate Specific Antigen (PSA) more than 20 ng/ml
- •Gleason score 8 or higher
- •IPSS score 19 or higher with alpha-blockers
- •Past radiation therapy to the pelvis
- •History of Collagen Vascular Disease
- •History of Inflammatory Bowel Disease
- •Bilateral Hip Prosthesis
研究组 & 干预措施
HDR brachytherapy monotherapy
Experimental
Radiation therapy: Treatment with 2 separate HDR brachytherapy implants, each with one fraction of 13.5 Gray (Gy) with an interval of 7-14 days between treatments.
干预措施: HDR brachytherapy monotherapy (Radiation)
结局指标
主要结局
Disease-free survival
时间窗: 5 years
Disease free survival as evaluated by absence of biochemical recurrence (Phoenix criteria) and absence of clinically/radiologically diagnosed local, regional or distant recurrence.
次要结局
- Genito-urinary (GU) toxicity(6 weeks, 2 years and 5 years post treatment)
研究者
Marc Gaudet
Radiation Oncologist
CSSS de Gatineau
研究点 (2)
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