A Continued Access Study to Evaluate Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- InSightec
- 入组人数
- 14
- 试验地点
- 5
- 主要终点
- Incidence and severity of device/procedure-related complications following treatment
研究概览
简要总结
This extended clinical investigation is a multicenter, prospective, single arm study intended to provide continued access of the Exablate Model 2100 device (Exablate Prostate) to patients for treatment of prostate lesions and collect additional safety and effectiveness data during the 510(k) preparation and review period.
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
- 50 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
- •Intermediate risk, organ-confined prostate cancer (T1a up to T2b) and voluntarily chooses Exablate, who may currently be on watchful waiting or active surveillance and not in need of imminent radical therapy
- •Up to 2 MRI visible Gleason 7 confirmed on mapping prostate biopsy that Investigator deems treatable within a single treatment session; may have secondary Gleason 6 on ipsilateral or contralateral side confirmed with biopsy and/or MRI
- •PSA less than or equal to 20ng/mL
排除标准
- •Evidence of distant prostate cancer including lymph node involvement and/or metastasis of cancer
- •Subject undergoing androgen deprivation therapy, initiating any new medication that can affect PSA, or history of bilateral orchiectomy
- •Active bladder cancer, active UTI, or untreated prostatitis
- •Untreated urethral stricture/bladder neck contracture
- •Prostate-specific chemotherapy, brachytherapy, cryotherapy, photodynamic therapy, radical prostatectomy, or focal therapy (excluding FUS); or any prior radiation therapy to the pelvis for prostate cancer or any other malignancy
- •Subjects with pathology or implants that may adversely impact treatment due to acoustics, imaging, or safe probe insertion
- •Subject not able or willing to tolerate the required prolonged stationary supine position during treatment
- •Contraindications to MRI
研究组 & 干预措施
Exablate Treated Arm
Treatment with Exablate Prostate 2100 Type-3 System
干预措施: Exablate Prostate Treatment (Device)
结局指标
主要结局
Incidence and severity of device/procedure-related complications following treatment
时间窗: 12 months
Safety will be evaluated by incidence and severity of device/procedure-related complications following treatment. Adverse events will be recorded and categorized according to severity and relationship to the biopsy procedure, the Exablate procedure, or to the Exablate device. They will be classified based on body system, severity, and frequency.
Proportions of treated subjects reporting negative Gleason 7 biopsy within the prostate biopsy treatment area.
时间窗: 6 months
Effectiveness will be evaluated by targeted lesion control based on biopsy results. Proportions of treated subjects reporting negative Gleason 7 biopsy within the treatment area and/or MRI verification of index lesion(s) ablation. PSA results and validated subject-reported questionnaires will be summarized.
次要结局
未报告次要终点