EUCTR2014-004296-22-FR进行中（未招募）1 期
Anticholinergics impact in the treatment of acute irritative urinary toxicity during radiotherapy for prostate cancer - VesiCaP
Centre Eugène Marquis0 个研究点开始时间: 2015年12月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •- Prostate localized adenocarcinoma (histological confirmation)
- •- Indication for prostate cancer radiotherapy (standard scheme with a global dose between 70 and 80 Gy)
- •- Patient affiliation to the French Social Security System
- •- Free and written informed consent
- •- Patients complaigning of urinary symptoms during irradiation
- •- Occurrence of overactive bladder subscore with the USP scale greater to 5 during irradiation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1- Pelvic irradiation contraindication
- •2- History of bladder or prostate surgery
- •3- History of pelvic radiotherapy
- •4- Person deprived of freedom, under tutorship,guardianship, safeguarding of justice
- •5- Age < 18
- •6- Qmax < 10 ml/sec at initial assessment, or post-void residual urine > 100 ml (during preinclusion urology visit)
- •7- Previous known Overactive Bladder
- •8- Patients treated with anticholinergic or anticholinesterasic within 12 months before irradiation
- •9- Patients treated with a-blocker, 5-alpha reductase inhibitors within 12 months before irradiation,
- •10- Contraindication of solifenacin succinate treatment :
- •- patients suffering from urinary retention, severe gastrointestinal disease (including toxic megacolon), myasthenia or angle-closure glaucoma, as well as patients at risk against these diseases
- •- patients suffering from hypersensitivity to active substance or to one of its excipients
- •- hemodialyzed patients
- •- patients suffering from severe hepatic insufficiency
- •- patients suffering from severe renal or moderate hepatic insufficiency and who are treated with a strong inhibitor of iso-enzyme CYP3A4 as Ketoconazole
- •11- Hypersensitivity or allergy to another anticholinergic
- •12- Hereditary intolerance to galactose, lactase deficiency (Lapp) or syndrome of glucose and galactose malabsorption
- •13- Patients unable to follow study medical requirement for family, social, geographical or psychic reasons
- •14- Participation to a clinical trial on urinary toxicity and / or substance that could modify this toxicity and its evolution.
研究者
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