EUCTR2013-005479-42-NL进行中（未招募）不适用
Pilot study: Toxicity of oestradiol for adjuvant endocrine therapy in locally confined prostate cancer - Oestradiol adjuvant trial (OAT)
Erasmus MC, Dept. Urology0 个研究点开始时间: 2014年2月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •1) Men = 18 years.
- •2) Locally advanced prostate cancer.
- •3) Selected for at least two years of adjuvant endocrine therapy and EBRT.
- •4) Signed informed consent.
- •5) Testosterone serum level > 6 nmol/l.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1) Current endocrine treatment or previous therapy within 6 months (5-alpha reductase inhibitors are permitted).
- •2) Previous radiological confirmed deep venous thrombosis or pulmonary embolus.
- •3) Cerebrovascular event (TIA or CVA) within 6 months.
- •4) Coronary heart disease within 6 months.
- •5) Instable angina pectoris within 6 months.
- •6) Congenital thrombofilic diseases.
- •7) Thrombolic disease within 6 months.
- •8) Heart failure as defined by NYHA class >2.
- •9) Hypertension (not corrected by medication) >160/100 mmHg. If either systolic or diastolic value is higher than these values the patient is not eligible.
- •10) Suboptimal regulated diabetes mellitus or de novo diabetes mellitus as defined by HbA1c of over 6,5% (48 mmol/mol).
- •11) Rheumatoid arthritis.
- •12) Impaired renal function as defined by a GFR < 30 ml/ min/1,73 m2
- •13) Acute liver failure or reduced liver function showing as increased serum parameters (SGOT, SGPT, bilirubine > 2.5 times normal).
- •14) Porfyria.
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