Focal Therapy Using High Intensity Focused Ultrasound (ABLATHERM®) for Localised Prostate Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Rate of patients without cancer
研究概览
简要总结
To evaluate the rate of patients without cancer detected by biopsies performed six months after hemi-ablation with high intensity focused ultrasound (HIFU) (Ablatherm ®).
Evaluate the impact of the HIFU treatment on continence, sexuality and quality of life at one year. Evaluate the cost of hemi-ablation HIFU treatment.
A prospective single -centre phase II, single arm, cohort study (therapeutic confirmatory) offering focal therapy using HIFU (Ablatherm ®) to 25 men with histologically proven localised low to intermediate risk prostate cancer (PSA ≤10ng/ml, Gleason score ≤ 7 ,T1c or T2b ). Precise mapping and characterisation of the disease will be established using multi-parametric (mp)-MRI and prostate biopsies. Only the lobe with disease will be treated.
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
- •Age≥ 50 years
- •Clinical stage T1c (normal digital rectal examination) or T2a (one palpable nodule on digital rectal examination)
- •PSA ≤10 ng / mL
- •Presence of cancer on biopsies (12 sampling biopsies plus 2-4 targeted biopsies on one side and limited to one or two contiguous areas of prostate: basic and middle or middle and apex).
- •Gleason score ≤ 7 (3+4)
- •Flowmetry > 12 mL / sec for a voided volume of 125 mL
- •PVR <100 mL
- •Patient with normal anal and rectal anatomy.
- •Patient with a condition corresponding to a classification of ASA 1 or
- •Patient signing ICF and agreed for following monitoring
排除标准
- •Patient with an ASA score
- •Patient in clinical stage T1a, T1b, T2b, T2c or T
- •Patient with a tumor visible on MRI: Located at a distance less than 5 mm from the midline. Located less than 6 mm from the apex real
- •Metastatic lymph node or metastasis discovered by MRI and bone scan.
- •Patient previously treated for his prostate cancer by hormone therapy.
- •Patient with a distance between the rectal mucosa and prostate capsule over 8 mm thick
- •History of inflammatory bowel disease
- •Rectal fistula.
- •History of pelvic radiotherapy.
- •History of bladder cancer.
- •History of bladder neck sclerosis or urethral stenosis.
- •Patient with an implant located less than 1 cm from the treatment zone (stent, catheter).
- •Urogenital infection.
- •Latex allergy
- •Contraindication to MRI (pacemaker,metal prosthesis ...)
- •Patient participated in another clinical study within 30 days.
- •Illiterate patients
- •Legally incapable patients
结局指标
主要结局
Rate of patients without cancer
时间窗: Six months
MRI,Biopsy,PSA
次要结局
- Impact of the hemi-ablation HIFU treatment on continence, sexuality and quality of life(One year)
- Immediate tolerance of hemi-ablation(One year)
- Cost of hemi-ablation HIFU treatment(One year)
研究者
Dr.Franck Bladou
MD. Professor of Oncology and Urology, McGill University
Jewish General Hospital