Pilot Study on Focal Prostate Radio-Frequency Ablation for the Treatment of Very-Low Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Negative Prostate Biopsy Rate at Six Months
研究概览
简要总结
This is a prospective pilot study. The purpose of this research study is to evaluate the safety and efficacy of focal Radio-Frequency Ablation (RFA) in men with low-risk, clinically localized prostate cancer.
详细描述
RFA is a minimally invasive procedure. It is an image-guided technique that heats and destroys cancer cells. In RFA, imaging techniques such as ultrasound or magnetic resonance imaging (MRI) are used to help guide a needle electrode into a cancerous tumor. High-frequency electrical currents are then passed through the electrode, destroying the cancer cells. Use of an RFA device was approved by the Food and Drug Association (FDA) in 1997 for the purposes of treating soft tissue tumors. The device we (Moffitt Cancer Center) will be using in this study has clearance for clinical use from the FDA. The effectiveness of the device is measured using biopsy cores at the site of the cancer after the RFA procedure. To evaluate the benefits of this procedure, we will also evaluate the change in quality-of-life indicators from baseline to 6 months following RFA. RFA is being developed as a minimally invasive potential treatment for prostate cancer.
This research study is a pilot clinical trial. Pilot clinical trials are smaller versions of larger studies that are conducted to prepare for the larger study. This pilot study pre-tests a research device before a large-scale multicenter study is launched.
The specific purpose of this pilot trial is to find out if RFA can effectively treat prostate cancer with fewer side effects including effects on urination, bowel function, and sexual function. RFA for early stage prostate cancer is designed to affect only the part of the prostate where cancer has been detected. The reasoning for this approach is the smaller the area given RFA, the less damage to surrounding tissues.
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
- •Diagnosis of adenocarcinoma of the prostate, confirmed by H.L. Moffitt Cancer Center review
- •No prior treatment for prostate cancer including hormonal therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Prostate Cancer Clinical Stage T1c
- •prostate-specific antigen (PSA) <10 ng/ml (this will be the PSA level prompting the initial prostate biopsy)
- •Prostate size <60 cc on transrectal ultrasound
- •If on anti-coagulation medications, must be able to suspend this therapy for a couple of weeks
- •Adequate organ function Pre-enrollment biopsy parameters (as per H.L. Moffitt Cancer Center review)
- •Minimum of 10 biopsy cores
- •No biopsy Gleason grade 4 or 5
- •Unilateral cancer (only right-sided or left-sided, not bilateral)
- •No more than 50% cancer in any one biopsy core
- •No more than 25% of cores containing cancer
排除标准
- •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
研究组 & 干预措施
Focal Prostate Radio-Frequency Ablation
Treatment is performed under a spinal or general anesthetic and will include the one to three regions of the prostate containing cancer based on the mapping biopsy.
干预措施: Radio-Frequency Ablation (RFA) ENCAGE™ (Procedure)
结局指标
主要结局
Negative Prostate Biopsy Rate at Six Months
时间窗: 6 Months
The primary efficacy endpoint is negative biopsy rate at 6 months after focal bipolar RFA. Evaluable patients for this study will be those who complete up through the six month follow-up/evaluation procedure.
次要结局
- Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months(6 Months)