NCT02328807已完成不适用
Focal Prostate Radio-Frequency Ablation for the Treatment of Prostate Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA)
研究概览
简要总结
The main purpose of this study is to evaluate the safety and efficacy of focal (targeted) Radio-Frequency Ablation (RFA) in men with low or intermediate-risk, clinically localized 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
- •Men 18 years of age or older
- •Diagnosis of adenocarcinoma of the prostate, confirmed by H.L. Moffitt Cancer Center review
- •No prior treatment for prostate cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or1
- •Prostate Cancer Clinical Stage T2a and below
- •PSA <10 ng/ml (this will be the prostatic specific antigen (PSA) level prompting the initial prostate biopsy)
- •Prostate size <60 cc on transrectal ultrasound
- •Pre-enrollment biopsy parameters (as per H.L. Moffitt C.C. review): Minimum of 10 biopsy cores; Gleason score 6 aor 7; Unilateral cancer (only right-sided or left-sided, not bilateral).
排除标准
- •Men less than 18 years of age
- •Medically unfit for anesthesia
- •Histology other than adenocarcinoma
- •Biopsy does not meet inclusion criteria
- •Men who have received any hormonal manipulation (antiandrogens; Luteinizing Hormone Releasing Hormone (LHRH) agonist; 5-alpha-reductase inhibitors) within the previous 6 months
结局指标
主要结局
Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA)
时间窗: 6 months
The primary efficacy endpoint is negative biopsy rate at 6 months after focal bipolar RFA. The point estimate and its 95% confidence interval will be calculated using the exact binominal method.
次要结局
- Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months(6 months)
- Number of Participants With Treatment Related Adverse Events(Up to 9 months)
研究者
研究点 (2)
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