NCT01377753已完成2 期
MR Image Guided Focal Therapy in Prostate Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of Participants With One Grade 1 Adverse Event, More Than One Grade 1 Adverse Event, and One Grade 2 Adverse Event
研究概览
简要总结
Background:
- One way to treat prostate cancer is to use a laser to direct extreme heat to a small area of the prostate. The heat destroys tumor cells but does not affect healthy tissue. Doctors want to see if magnetic resonance imaging (MRI) can be used to improve this treatment. MRI will be used to help locate tumor cells and guide the laser during surgery. However, MRI-guided laser therapy has not been used to treat many people with prostate cancer. More studies are needed to see whether it can destroy tumor cells permanently.
Objectives:
- To test the safety and effectiveness of treating prostate tumors with laser therapy guided by magnetic resonance imaging.
Eligibility:
- Men at least 18 years of age who have prostate cancer that can be seen with an MRI and has not spread to other parts of the body.
Design:
- Participants will be screened with a physical exam and medical history. They will also have blood tests and imaging studies, and will complete questionnaires about their health.
- Participants will have the MRI-guided laser treatment in the hospital. The doctor will use the MRI to control how much energy is delivered by the laser and how much tissue is destroyed. The entire procedure usually takes from 1.5 to 3 hours.
- After the treatment, participants will have a catheter put in to keep the bladder emptied. The catheter will stay in for 1 to 7 days. Drugs to prevent infection and bladder spasms will be given. Participants will leave the hospital once they are well enough to go home.
- Participants will have follow-up visits 3, 6, 9, 12, 18, 24, and 36 months after the therapy. They will have physical exams, and blood and urine tests. They will also answer questionnaires. Participants will have MRI scans 6, 12, 24, and 36 months after the therapy. They will have a prostate biopsy to see if there is any tumor every 12 months for the first 2 years. Another biopsy may be done in the third year.
详细描述
Background:
- Pilot study is designed to evaluate the safety and feasibility of thermal laser ablation of focal prostate tumors.
- Prostate cancer is relatively slow growing, with doubling times for local tumors estimated at 2 to 4 years.
- Some prostate cancers prove to be small, low grade, and noninvasive and they appear to pose little risk to the life or health of the host. Recent patient series suggest that 20% to 30% of men undergoing radical prostatectomy have pathologic features in the radical prostatectomy specimen consistent with an insignificant or indolent cancer which poses little threat to life or health.
- We propose that patients with low volume and low grade disease can be best served with focal ablation of the visible prostate cancer without the side effects of urinary incontinence and erectile dysfunction associated with radiation therapy or radical surgery.
Objectives:
Primary Objective:
-To determine feasibility and safety of magnetic resonance image-guided focal laser ablation of biopsy confirmed and magnetic resonance (MR) visible 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants With One Grade 1 Adverse Event, More Than One Grade 1 Adverse Event, and One Grade 2 Adverse Event
时间窗: For all participants enrolled over the time frame of the study including follow up time is approximately 65 months
Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 is mild and Grade 2 is moderate.
次要结局
- Mean Change in Prostate Specific Antigen (PSA) From Baseline Prior to Salvage Treatment or at the Conclusion of the Study Time Frame if There Was No Salvage Treatment(From date participant is enrolled to completion of post-ablation monitoring, approximately 3 years.)
- Mean Change in Quality of Life (QoL) From Baseline Prior to Salvage Treatment or at the Conclusion of the Study Time Frame if There Was No Salvage Treatment(From date participant is enrolled to completion of post-ablation monitoring, approximately 3 years.)
- Mean Change in International Prostate Symptom Score (IPSS) From Baseline Over Follow-Up Visits Prior to Salvage Treatment or Across All Follow-up Visits During Study Time Frame if There Was No Salvage Treatment(From date participant is enrolled to completion of post-ablation monitoring, approximately 3 years.)
- Mean Change in Prostate Specific Antigen Density (PSAD) From Baseline During Study Time Frame(From date participant is enrolled to completion of post-ablation monitoring, approximately 3 years.)
- Mean Change in Sexual Health Inventory for Men (SHIM) From Baseline Over Follow-Up Visits Prior to Salvage Treatment or Across All Follow-up Visits During Study Time Frame if There Was No Salvage Treatment(From date participant is enrolled to completion of post-ablation monitoring, approximately 3 years.)
研究者
Peter Pinto, M.D.
Principal Investigator
National Cancer Institute (NCI)
研究点 (2)
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