NCT04972097已完成不适用
Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue in an Intermediate-Risk Patient Population
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 30
- 主要终点
- Incidence of adverse events by type and CTCAE v5.0 severity through 12 months
研究概览
简要总结
Pivotal study to evaluate the use of the NanoKnife System as a focal therapy option for prostate cancer patients. This study will assess the safety and effectiveness of the device when used to ablate prostate tissue in intermediate-risk prostate cancer patients.
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
- •Is greater than 50 years of age
- •Has at least a 10-year life expectancy
- •Has histologically confirmed organ-confined prostate cancer, clinical stage ≤ T2c
- •Has a PSA ≤ 15 ng/mL or PSA density < 0.2 ng/mL2 if PSA is > 15 ng/mL
- •Has Gleason score 3+4 or 4+3
- •Has no evidence of extraprostatic extension by mpMRI
- •Has no evidence of seminal vesicle invasion by mpMRI, and if suspected, confirmed by biopsy
- •Physician is able to visualize prostate gland adequately on transrectal ultrasound imaging during enrollment evaluation
- •Transperineal or transrectal targeted prostate biopsies of lesion, plus 10 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 (Note: A non-MRI visible lesion detected via systematic standard biopsy will not be considered an exclusion criterion provided the non-MRI visible lesion is singularly located in the contralateral hemisphere of the prostate; is Gleason 6; and comprises no more than 6 mm linear extent of prostate-bearing tissue in a single core on standard biopsy)
- •Has signed a written informed consent and in the judgment of the physician, the study is in the best interest of the subject
- •Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits
排除标准
- •Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium
- •Is unfit for anesthesia or has a contraindication for agents listed for paralysis
- •Has an active urinary tract infection (UTI)
- •Has a history of bladder neck contracture
- •Is interested in future fertility
- •Has a history (within 3 years) of inflammatory bowel disease
- •Has a concurrent major debilitating illness
- •Had active treatment for a malignancy within 3 years, including malignant melanoma, except for prostate cancer or other types of skin cancer
- •Has any active implanted electronic device (e.g., pacemaker)
- •Is unable to catheterize due to a urethral stricture disease
- •Has 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
- •Has had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or prostatic implants
- •Has had prior major rectal surgery (except hemorrhoids)
- •Is 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))
- •Is actively bleeding, is anticoagulated or on blood thinning medications, or has a bleeding disorder
- •Is a member of a vulnerable population such as prisoners, handicapped or mentally disabled persons, or economically or educationally disadvantaged persons
- •In the opinion of the treating physician, has a contraindication listed in the current NanoKnife System User Manual (section 2.3)
研究组 & 干预措施
IRE Treatment Arm
Experimental
All patients enrolled in this trial will receive IRE treatment with the NanoKnife System
干预措施: Irreversible Electroporation (Device)
结局指标
主要结局
Incidence of adverse events by type and CTCAE v5.0 severity through 12 months
时间窗: 12 months
To determine the NanoKnife System's procedural and post-procedural safety profile by evaluation adverse event incidence, type, and severity through 12 months
Rate of negative in-field biopsy at 12 months
时间窗: 12 months
To determine the NanoKnife System's ablation effectiveness by measuring the negative in-field biopsy rate at 12 months
次要结局
- Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics(12 months)
- Assessment of changes in prostate volume(12 months)
- Assessment of ablation effectiveness by evaluation of prostate tissue by mpMRI(12 months)
- Rate of negative in-field biopsy at 12 months as defined by the Delphi consensus criterion(12 months)
- Assessment of urinary function by comparison of pre- and post-operative UCLA Expanded Prostate Cancer Index Composite(12 months)
- Assessment of erectile function by comparison of pre- and post-operative IIEF-15 potency scores(12 months)
- Assessment of need for secondary or adjuvant treatment(12 months)
- Evaluation of subject reported pre- and post-operative Quality of Life(12 months)
研究者
研究点 (30)
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