Phase 1 Study: A Prospective, Multi-center, Single Arm Study - Evaluation of the Safety and Feasibility of MRI-guided Transurethral Ultrasound Therapy for the Ablation of Prostate Tissue in Patients With Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Safety - Evaluate the Frequency of Treatment Related Adverse Events
研究概览
简要总结
This study is to evaluate that the magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system is safe and feasible to ablate prostate tissue in men with localized prostate cancer.
详细描述
Profound Medical Inc. has developed a novel technology called the MRI-guided transurethral ultrasound therapy system. The technology is developed for patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue.
The treatment is conducted completely within an MRI suite, which enables real-time temperature images of the heated region to be acquired as the ultrasonic treatment is delivered. Using MRI thermometry during treatment, dynamic temperature feedback control over the intensity of the ultrasound beams and rotation of the Ultrasound Applicator can shape the pattern of thermal coagulation accurately and precisely in the prostate gland, thereby reducing the risk of possible damage to important surrounding anatomy such as the rectum, urinary sphincters, neurovascular bundles and pelvic bone. This coagulation method, therefore, has the potential to have lower complication rates than conventional therapies.
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
- 65 Years 至 75 Years（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, age ≥65
- •Patient with low-risk, early-stage organ-confined prostate cancer (Stage T1c or T2a, N0, M0).
- •Gleason score 6 (3+3)
- •Prostate-specific antigen (PSA) ≤ 10 ng/ml
- •Eligible for MR imaging (DOC-10252)
- •Meets the following criteria on pre-treatment transrectal ultrasound imaging:
- •No cysts or calcifications > 1.0 cm in size
- •No evidence of extraprostatic extension or seminal vesicle invasion
- •Overall prostate size less than 5 cm in sagittal length and less than 7 cm in diameter
- •Biopsy confirmed adenocarcinoma of the prostate, performed at least 6 weeks prior to and no more than 6 months prior to the scheduled treatment.
- •Eligible for General Anesthesia, as defined in American Society of Anesthesiologists (ASA)
- •Normal rectal anatomy and rectal mucosa on digital rectal examination
排除标准
- •Bleeding disorder
- •Abnormal coagulation and current anticoagulant therapy.
- •Acute or chronic Urinary Tract Infection
- •Interest in future fertility
- •History of allergy relevant medication or other
- •History of any other malignancy other than skin cancer
- •Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome
- •Prior treatment of the prostate gland
- •Prior treatment with 5 alpha reductase inhibitor allowed (not as prostate cancer treatment or prevention) as long as drug has been stopped for minimum 3 months
- •History of any major rectal or pelvic surgery
- •History of ulcerative colitis or other chronic inflammatory conditions affecting rectum
- •History of documented clinical prostatitis requiring therapy within previous 6 months
- •History of urethral and bladder outlet disorders, including urethral stricture disease, urethral diverticulae, bladder neck contracture, urethral fistulae which had required prior urethrotomy, urethral stenting, urethroplasty or chronic indwelling urethral catheter
- •Patients with artificial urinary sphincter or any penile implant (metallic or non-metallic)
- •Neurologic bladder disorders
- •Untreated bladder stones
- •History of acute urinary retention
- •Confirmed or suspected bladder cancer
- •Urinary sphincter abnormalities
- •Active untreated gross hematuria for any cause
- •Post Void Residual (PVR) bladder volume > 250 mL
- •Obstructing median lobe enlarged out of proportion to the rest of the prostate and protruding significantly into the bladder
- •Additional exclusion criteria on file....
结局指标
主要结局
Safety - Evaluate the Frequency of Treatment Related Adverse Events
时间窗: 12 months from the Treatment Date
All reported adverse events were recorded. The frequency was measured as the number of study participants who experienced a treatment/device related adverse event after receiving treatment delivery with PAD-105, the investigational device.
Safety - Evaluate the Severity of Treatment Related Adverse Events
时间窗: 12 months from the Treatment Date
Severity of treatment/device related adverse events were evaluated in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard (version 4), published by the National Cancer Institute (NCI). There was no intraoperative complication, no rectal injury or fistula and no severe urinary incontinence. No Grade 4 (G4) or higher adverse events and only one attributable Grade 3 (G3) event; reported below. The common and significant Grade 1 (G1) and Grade 2 (G2) genitourinary events have also been reported.
次要结局
- Feasibility - Evaluate the Effectiveness of the Investigational System to Thermally Coagulate Prostate Tissue Conforming to the Target Volume With a High Degree of Accuracy and Precision(On Treatment Date)