EUCTR2011-004749-41-NL进行中（未招募）不适用
The effects of neoadjuvant hormonal therapy on the course of PSA and testosterone in patients with low and intermediate-risk prostate carcinoma (NEO-ONE); A randomized controlled trial - NEO-ONE
TweeSteden hospital0 个研究点开始时间: 2011年11月17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
- •Patients with low and intermediate risk prostate cancer who are planned for low dose brachytherapy, with a prostate volume between 35 and 50 cc, with a life expectancy of at least 10 years and an ECOG performance status of 2 or less11.All patients will need to provide written informed consent.
- •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 300
排除标准
- •Study exclusion criteria are: PSA =20, Gleason score =8, Prostate volume =55 cc, Stage =T2B, bone metastasis, intraprostatic cavity (e.g. extensive TURP effect), hip abnormalities, use of anticoagulants that are unable to be discontinued for the duration of the operation. Further, we exclude patients that are characterized by
- •·use of hormone suppressive therapy in the past or surgical castration.
- •·use of 5 alfa reductase in the last 6 months
- •·use of estrogens
- •·Taking systemic glucocorticoids
- •·Kidney or liver dysfunction, as biochemically assessed by the glomerular filtration rate of creatinin (MDRD formula; GFR <50 ml/m2/min) and ASAT and ALAT levels (50% reduction in function)
- •·Cognitive impairments (ECOG performance <2)
- •·Negative decision for study participation by the hospitals’ urology-radiotherapy meeting
- •·A history of myocardial infarction with present symptoms or CAD-induced (systolic) congestive heart failure
研究者
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