DRKS00005179尚未招募未知
High intensity focused ultrasound (HIFU) and Eligard in patients with high risk prostate cancer - HELP
niversitätsklinikum Magdeburg A.ö.R.Dekan der Medizinische FakultätProf. Dr. Hermann-Josef-Rothkötter0 个研究点目标入组 60 人开始时间: 2013年10月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- Male
入选标准
- •Prostate cancer, classification by D´Amico High Risk”, meaning PSA > 20 ng/mL and/or
- •Gleason-Score = 8 and/or
- •cT-Kategorie = 2c
- •Clinical tumor stadium cT1c to cT3
- •Life expectancy of at least 10 years
- •Patients for whom radical prostatectomy is not an option or who re-fuse this procedure
- •Patients for whom radiotherapy is not an option or who refuse this procedure.
- •Normal anatomy of rectum and rectal wall
- •ASA classification of 1, 2 or 3 with good general health and life expectancy of at least 10 years
- •Karnofsky index = 80%
- •Patient must be mentally competent and able to complete the various questionnaires on symptoms and quality of life in their entirety
- •Patient must be willing to leave the choice between the two therapies to chance
- •Intention and possibility to attend all necessary follow-up appoint-ments and submit to all necessary study procedures
- •Voluntary consent to study participation after complete disclosure of the nature and purpose of the study, confirmed by signature on the consent document.
排除标准
- •Neuroendocrine classification of prostate cancer
- •Clinical T4 tumor in rectal area (digital examination)
- •Previous radical treatment of prostate cancer
- •Previous hormone therapy for prostate cancer
- •Seed implants (brachytherapy)
- •Shadow-producing calcification in the prostate that can significantly disturb treatment (inclusion possible after TURP)
- •Pre-existing urethral strictures or bladder neck spasm (the patient may be included after treatment has been carried out)
- •Pre-existing urinary infections or prostatitis (the patient may be in-cluded after the infection has been treated)
- •Reduced kidney function (creatinine > 160 mmol/L)
- •Rectal fistula
- •Patients with intraprostatic implants, such as stents or catheters, or any type of prosthesis or implant with the exception of a suprapubic catheter for urinary diversion
- •Thermotherapy or hyperthermia treatment within the past 3 months
- •Patients interested in retaining their fertility
- •Patients who have participated in other clinical or pharmacological studies in the past 30 days
研究者
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