A Study to Evaluate the Safety and Efficacy of Focal US Guided Cryo-ablation Using DynaCAD / UroNAV Preplanning / Guidance of Locally Confined Low to Intermediate Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Assessment of safety of the DynaCAD /UroNAV ablation planning and guidance system aided cryo-ablation in the treatment of low-intermediate risk, localized (organ confined) prostate cancer tumors.
研究概览
简要总结
The purpose of this research study is to determine the safety and feasibility of using the UroNav software and DynaCAD software for planning and treating prostate cancer as an add on to the already approved workflow of using ultrasound only during the cryoablation of the prostate. The software application may aid doctors in locating a prior biopsy proven cancer location from the UroNav biopsy that patients previously had and then use that information to guide the treatment.
详细描述
This is a single-center, prospective, single arm study to evaluate feasibility of UroNAV Ablation system aided cryo-ablation treatment of low and intermediate risk, organ-confined prostate cancer. All subjects will be treated and then followed up clinically for up to 24 months to evaluate any procedure or device related adverse events as well as to assess efficacy endpoints of the study. Additional data related to quality of life of treated subjects will also be collected
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients must have documented histological or cytological evidence of tumor(s) of the prostate.
- •Patients must be ≥ 45 years of age.
- •Patients must be able to read, understand and sign an informed consent.
- •Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on MR imaging.
- •Prostate cancer is diagnosed by MR image guided biopsies.
- •Gleason Score ≤ 7; and 2 or less positive lesions on prior MR US fusion guided prostate biopsy.
- •A non MRI visible cancer detected via systematic standard biopsy will not be considered an exclusion condition provided the non-MRI visible cancer is singularly located in the contralateral hemisphere of the prostate; is Gleason 6 cancer; and comprises no more than 6mm linear extent of cancer in a single core on standard biopsy.
- •If any standard biopsy cores are positive on the same hemisphere of the prostate gland, they must be confirmed as likely to form a contiguous lesion with the target lesion detected on MRI and therefore be from the same location in the prostate as MR lesion was biopsied and proven to be cancerous. (e.g., Left/Right, Base, Mid Gland, Apex).
- •Prior mpMRI results dated within 120 days prior to ablation.
- •No metastatic disease as per NCCN guidelines (www.nccn.org) - Bone scan indicated to r/o metastatic disease if clinical T1 and PSA > 20 or T2 and PSA > 10
- •PSA < 15 ng/ml or PSA density < 0.15 ng/ml2 in patients with a PSA > 15 ng/ml.
排除标准
- •ASA status > 3
- •Very Low Risk Prostate Cancer based on Epstein's Criteria having a tumor <0.2 cc (AUA Guidelines 2017 pg. 9)
- •GG1, PSA < 10 ng/ml, no more than two positive cores and no core > 50% involvement.
- •Contraindications to MRI
- •3.1 Claustrophobia
- •3.2 Implanted ferromagnetic materials or foreign objects
- •3.3 Known intolerance to the MRI or US contrast agents.
- •3.4 Severely abnormal coagulation (INR>1.5)
- •Patients with unstable cardiac status including:
- •4.1 Unstable angina pectoris on medication
- •4.2 Patients with documented myocardial infarction within 40 days prior to enrolment
- •4.3 Congestive heart failure NYHA class IV
- •4.4 Patients with unstable arrhythmia status, already on anti-arrhythmic drugs
- •Severe hypertension (diastolic BP > 100 on medication)
- •Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
- •History of orchiectomy, PCa-specific chemotherapy, brachytherapy, cryotherapy, Photodynamic therapy or radical prostatectomy for treatment of prostate cancer; any prior radiation therapy to the pelvis for prostate cancer or any other malignancy.
- •Patient under medications that can affect PSA for the last 3 months prior to UroNAV Ablation system aided cryo-ablation treatment (Androgen Deprivation Treatment)
- •Patients with lesions of Gleason 7 or greater outside the planned treatment area.
- •Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (approximately 3 hrs.)
- •Any rectal pathology, anomaly or previous treatment, which could change acoustic properties of rectal wall or prevent safe US probe insertion (e.g., fistula, stenosis, fibrosis, inflammatory bowel disease, etc).
- •Any spinal pathology which can prevent safe administration of epidural/spinal anesthesia
- •Evidence for lymph node involvement of cancer
- •Bladder cancer
- •Urethral stricture/bladder neck contracture
- •Patients with incontinence demonstrated by use of more than 1 pad/day. .
- •Prostatitis NIH categories I, II and III.
- •Compromised renal function
- •Interest in future fertility
- •Current participation in another clinical investigation of a medical device or a drug or has participated in such a study within 30 days prior to study enrollment.
结局指标
主要结局
Assessment of safety of the DynaCAD /UroNAV ablation planning and guidance system aided cryo-ablation in the treatment of low-intermediate risk, localized (organ confined) prostate cancer tumors.
时间窗: 24 months
Incidence and severity of device/treatment related complications from treatment day visit through 24 month follow up.
次要结局
- Assessment of tumor control achieved by treatment.(24 months)
研究者
Ardeshir Rastinehad
Associate Professor of Urology and Radiology, Vice Chair of Urology at Lenox Hill Hospital, System Director for Prostate Cancer
Northwell Health