NCT02766543进行中（未招募）不适用
Evaluation of the TULSA-PRO MRI-Guided Transurethral Ultrasound Prostate Ablation Device in Patients With Localized Prostate Cancer: a Prospective, Single-Arm, Pivotal Clinical Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 28
- 主要终点
- Safety Endpoint - Incidence of treatment-emergent adverse events
研究概览
简要总结
A prospective, multi-center, single-arm study, planned in 150 patients. The primary objective of the study is to further evaluate the safety and efficacy of a magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO) intended to ablate prostate tissue of patients with localized, organ-confined prostate cancer.
详细描述
Profound Medical Inc. has developed a novel technology called the MRI-guided transurethral ultrasound therapy system (TULSA-PRO). 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 within a 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.
It provides advantages of a non-invasive procedure with short treatment times.
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
盲法说明
Open Label
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, age 45 to 80 years
- •Biopsy-confirmed adenocarcinoma of the prostate. Biopsy (minimum 10 cores) obtained ≥ 6 weeks and ≤ 6 months before treatment (or at the discretion of PI and approval by the Sponsor).
- •Clinical stage ≤ T2b
- •4.1 Gleason score ≤ 3 + 4 (Part I only)
- •4.2 Gleason score 3+4 (Part II only) *now recruiting
- •PSA ≤ 15 ng/ml
- •Eligible for MRI [Form GCP-10131]
- •Eligible for general anesthesia (ASA category ≤ 3)
- •Prostate volume ≤ 90 cc, on Baseline MRI
- •Prostate size ≤ 5.0 cm in sagittal length, and ≤ 6.0 cm in axial diameter, on Baseline MRI
- •Life expectancy ≥ 10 years
- •No calcifications in the planned ultrasound beam path, or at the discretion of the investigator with approval from the Sponsor.
排除标准
- •Evidence (including Baseline MRI and bone scan) of extracapsular extension, sphincter involvement, seminal vesicle invasion, lymph node invasion or metastases
- •Suspected tumour on Baseline MRI within 3 mm of the prostatic urethra, or in the prostate apex within 3 mm from the sphincter plane
- •Prior definitive treatment of prostate cancer
- •Prior transurethral resection of the prostate (TURP)
- •Use of 5-alpha reductase inhibitors (5-ARIs) or hormone therapy within 3 months prior to the baseline visit. Baseline PSA must be established after a minimum of 3 months following 5-ARIs discontinuation. Additionally, use of 5-ARIs is not permitted following treatment during the study follow-up period.
- •Prostate calcifications > 1 cm in largest diameter, on Baseline Ultrasound
- •Cysts > 1 cm in largest diameter, on Baseline MRI
- •Bleeding disorder (INR > ULN and PTT > ULN)
- •Abnormal coagulation and current anticoagulant therapy. Patients whose anticoagulation therapy can be temporarily reversed within 7 days prior to treatment are eligible. Platelet inhibitors (ie: ASA) and heparin are not exclusion criteria.
- •Acute unresolved Urinary Tract Infection (UTI)
- •Interest in future fertility
- •History of any other malignancy other than skin cancer, or low grade bladder cancer which has been completely resected, within the previous 2 years. Patients that have had curative treatment of a previous malignancy and no recurrence of that malignancy within the past 2 years will be allowed.
- •Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome
- •Patients with diabetes who have evidence of complications from their diabetes, such as end organ sequelae of diabetes or Hemoglobin A1c > 7%.
- •History of any major rectal or pelvic surgery or radiotherapy
- •History of ulcerative colitis or other chronic inflammatory conditions affecting rectum (includes rectal fistula, anal stenosis)
- •Documented clinical prostatitis requiring therapy within 6 months prior to Treatment
- •History of urethral and bladder outlet disorders, including urethral stricture disease, urethral diverticulae, bladder neck contracture, urethral fistulae, urethral stenting, urethral sling, urethroplasty or chronic indwelling urethral catheter
- •Patients with artificial urinary sphincter or any penile implant
- •Severe neurogenic bladder
- •Untreated bladder stones
- •History of acute urinary retention within the last 12 months
- •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, sometimes referred to as "ball valve" median lobe, determined on Baseline MRI
- •Any prostate related investigational therapy within 6 months of Visit 1
- •History of Parkinson's disease or multiple sclerosis
- •History of drug abuse
- •Known infectious disease including HIV positivity or AIDS-related illness, HBV and HCV
- •Current unilateral or bilateral hydronephrosis
- •Allergy or contraindications to administration of the GI anti-spasmodic drug:
- •Patients in the USA: Glucagon
- •Patients in Canada and Europe: Buscopan (Hyoscine)
- •Contraindications to administration of gadolinium-based MRI contrast agent (e.g. Magnevist), such as chronic, severe kidney disease, acute kidney injury, history of Sickle Cell Disease, history of anemia, or intolerance/allergy to the contrast agent
- •Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results
结局指标
主要结局
Safety Endpoint - Incidence of treatment-emergent adverse events
时间窗: 1 year
Frequency and severity of all adverse events will be evaluated by attribution and reported in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
Efficacy Endpoint - Proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value.
时间窗: 1 year
Prostate ablation efficacy will be evaluated using the proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value.
次要结局
- Erection Firmness Endpoint(At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).)
- Prostate Volume Endpoint(1 year)
- CE-MRI Endpoint(Immediately after treatment)
- PSA Nadir Endpoint(1 year)
- mpMRI Endpoint(1 year)
- Erectile Dysfunction Endpoint(At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).)
- IPSS Endpoint(At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).)
- IIEF Endpoint(At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).)
- EPIC Endpoint(At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).)
- Targeting Accuracy Endpoint(During treatment)
- Urinary Incontinence Endpoint(At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).)
- PSA Stability Endpoint(At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).)
- Prostate Biopsy Endpoint(1 year)
研究者
研究点 (28)
Loading locations...
相似试验
招募中
2 期
Evaluation of the TULSA-PRO MRI-Guided Transurethral Ultrasound Prostate Ablation Device in Patients with Localized Prostate Cancer: a Prospective, Single-Arm, Pivotal Clinical StudyProstate carcinoma10038597Prostate cancerNL-OMON42845Profound Medical, Inc.12
已完成
不适用
Safety Study of MRI-guided Transurethral Ultrasound Ablation of Prostate Tissue to Treat Localized Prostate CancerProstate CancerNCT01686958Profound Medical Inc.30
招募中
不适用
MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Low to Intermediate Grade Prostate CancerProstate CarcinomaStage I Prostate Cancer AJCC v8Stage II Prostate Cancer AJCC v8NCT05438563Mayo Clinic100
终止
3 期
Efficacy and Safety of a Single TRUS-guided Intraprostatic Injection of NX-1207 in Patients With LUTS Due to BPHLower Urinary Tract SymptomsNCT02003742RECORDATI GROUP104
已完成
不适用
MRI Guided Transurethral HIFU for Various Prostate DiseasesLocalised Prostate CancerLocally Advanced Prostate CancerLocally Recurrent Prostate CancerBenign Prostatic HyperplasiaNCT03350529Turku University Hospital87