A Pilot Study in Human Subjects Evaluating the Use of the NanoKnife System for Ablation of Prostate Cancer Tissue in an Intermediate Risk Patient Population
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Treatment Morbidity Profile
研究概览
简要总结
The purpose of this study is to evaluate the feasibility and short-term safety and effectiveness of the NanoKnife System when used to ablate localized prostate cancer in intermediate risk subjects with organ-confined prostate cancer. This study will evaluate the feasibility of the NanoKnife System as a focal therapy.
详细描述
This study will involve six (6) subjects who meet the intermediate risk prostate cancer criteria defined by this protocol. The biopsy and imaging techniques that we will adopt within this trial are multiparametric MRI (mpMRI) and transperineal prostate biopsy (template mapping and/or limited targeted). The subjects' prostate cancer foci, the location of which will be determined by ultrasound guided transperineal prostate biopsy, will be targeted for treatment with the NanoKnife System. The primary objective of this the study will be to evaluate procedural and short-term post treatment safety of the NanoKnife treatment via incidence of adverse events and evaluation of effect on urologic (urinary and erectile) function. The secondary objective of this study is to evaluate the short term efficacy of the NanoKnife treatment. Local efficacy in the area of treatment will be assessed by histological evaluation of transperineal prostate biopsy cores at six (6) months post NanoKnife treatment, to evaluate the ablation zone created by the NanoKnife treatment. Other secondary outcomes include health-related quality of life levels evaluated using validated patient questionnaires. Following the 6 month transperineal prostate biopsy and mpMRI assessment, the data from these 6 subjects will be submitted to FDA for confirmation of short term safety and efficacy.
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
- •Has at least a 10-year life expectancy
- •Have histologically confirmed organ-confined prostate cancer - clinical Stage ≤ T2c
- •Have a PSA ≤ 15 ng/mL or PSA density < 0.15 ng/mL2 if PSA is > 15 ng/mL
- •Has Gleason score 3+4 or 4+3
- •Has 10 mm or less of cancer-bearing prostate tissue in any biopsy core
- •No evidence of extraprostatic extension or seminal vesicle invasion by mpMRI
- •Able to visualize prostate gland adequately on transrectal ultrasound imaging during enrollment evaluation
- •Transperineal targeted prostate biopsies of lesion, plus 12 core systematic biopsies to include adequate sampling of the peripheral zone correlating with an intermediate risk lesion in the area of the MR-visible lesion.
- •A visible lesion on mpMRI that is accessible to Irreversible Electroporation (IRE) treatment
- •A non-MRI visible lesion detected via systematic standard biopsy will not be considered an exclusion condition provided the non-MRI visible lesion is singularly located in the contralateral hemisphere of the prostate; is Gleason 6; and comprises no more than 6mm linear extent of cancer-bearing tissue in a single core on standard biopsy.
- •Must sign a written informed consent
- •Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits
排除标准
- •Have known hypersensitivity to pancuronium bromide, atricurium or cisatricurium
- •Unfit for anesthesia or have a contraindication for agents listed for paralysis
- •Have an active urinary tract infection (UTI)
- •Have a history of bladder neck contracture
- •Are interested in future fertility
- •Have a history (within 3 years) of inflammatory bowel disease
- •Have a concurrent major debilitating illness
- •Had a malignancy within 5 years, including malignant melanoma, except for prostate cancer or other types of skin cancer
- •Have any active implanted electronic device (e.g., pacemaker)
- •Are unable to catheterize due to a urethral stricture disease
- •Have had prior or current prostate cancer therapies:
- •Biologic therapy for prostate cancer
- •Chemotherapy for prostate cancer
- •Hormonal therapy for prostate cancer within three months of procedure
- •Radiotherapy for prostate cancer
- •Surgery for prostate cancer
- •Have had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or prostatic implants
- •Have had prior major rectal surgery (except hemorrhoids)
- •Unfit for pelvic MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, metallic implants that are likely to contribute significant image artifacts, allergy or contraindication to gadolinium (to enhance MRI)
结局指标
主要结局
Treatment Morbidity Profile
时间窗: 6 months
To determine the NanoKnife treatment morbidity profile by evaluating urinary and erectile function.
Treatment procedural and short-term post-treatment safety profile
时间窗: 6 months
To determine the NanoKnife treatment procedural and short-term post-treatment safety profile by evaluating adverse event incidence, type, duration, severity and relationship to study device.
次要结局
- Completeness of Ablation(6 months)
- Prostate-Specific Antigen Kinetics(24 months)
- Health-Related Quality of Life(24 months)
- Effectiveness of Therapy(24 months)