NCT02265159Unknown2 期
Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound for the Treatment of Prostate Cancer
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Oncological safety
研究概览
简要总结
The investigators aim to evaluate cancer control, genitourinary, rectal and overall health-related quality of life outcomes and effectiveness of focal therapy for localised prostate cancer using High Intensity Focused Ultrasound (HIFU).
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
- 40 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically proven prostate cancer on trans-rectal or transperineal template prostate biopsies
- •Template biopsy:
- •unilateral disease (Gleason ≤4+3)
- •bilateral disease: presence of clinically significant cancer in both sides (Gleason ≤4+3) OR clinically insignificant disease with a burden of >50% of biopsy cores taken on that side, OR bilateral clinically insignificant disease and <50% of biopsy cores positive on any one side but with dominant disease burden on one side
- •Stage T1-T2cN0M0 disease, as determined by local guidelines (radiological T3a permitted)
- •Serum PSA ≤15
- •Life expectancy of ≥10 years
- •Signed informed consent by patient
- •An understanding of the German language sufficient to understand written and verbal information about the trial and consent process
排除标准
- •Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer
- •Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
- •Men with an inability to tolerate a transrectal ultrasound
- •Men with latex allergies as the HIFU probe is covered with a latex condom sheath prior to insertion into the back passage
- •Men who have undergone prior significant rectal surgery preventing insertion of trans-rectal HIFU probe (decided on the type of surgery in individual cases)
- •Men who have had previous HIFU, cryosurgery, thermal or microwave therapy to the prostate.
- •Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within 6 months. These patients may be included within the trial if deferred from consenting and screening until at least 6 months following the TURP.
- •Men not fit for major surgery as assessed by a Consultant Anaesthetist
- •Men unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant etc likely to contribute significant artefact to images)
- •Presence of metal implants/stents in the urethra
- •Presence of prostatic calcification and cysts (on transrectal ultrasound) whose location will interfere with effective delivery of HIFU therapy
- •Men with renal impairment with a glomerular filtration rate of <35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI).
结局指标
主要结局
Oncological safety
时间窗: 36 months
To determine the proportion of men who are free of clinically significant prostate cancer in the treated area AND are free of clinically significant prostate cancer in the untreated area 36 months after focal therapy using HIFU
次要结局
- Biochemical failure(36 months)
- Health care costs(36 months)
- Lower urinary tract symptoms(36 months)
- Sensitivity and specificity of MRI imaging(36 months)
- Orgasmic function(36 months)
- Sexual function(36 months)
- Anxiety(36 months)
- Bowel function(36 months)
- Secondary intervention(36 months)
- Quality of life(36 months)
- General histological outcome(36 months)
- Erectile function(36 months)
- Continence(36 months)
研究者
Daniel Eberli
PD Dr. med. PhD
University of Zurich
研究点 (2)
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