ISRCTN47114653已完成未知
An open-label, prospective, comparative trial to assess prostate specific antigen progression on bicalutamide monotherapy versus bicalutamide and dutasteride therapy in patients with advanced and/or metastatic carcinoma of the prostate
Foundation for the Promotion of Urological Scientific Research (STIWU) (The Netherlands)0 个研究点目标入组 150 人开始时间: 2006年11月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
2018 results in https://www.ncbi.nlm.nih.gov/pubmed/27330919 (added 24/01/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Patients aged 18 years and above
- •2. Patients with histologically proven prostate cancer
- •3. Patients with locally advanced carcinoma of the prostate (T3-4, N0-x) or (T0-x, N1-3; N category should be confirmed histologically or cytologically) or metastatic carcinoma of the prostate (M1)
- •4. Patients with a high (more than 10 ng/ml) PSA level at baseline
- •5. Written informed consent to participate in the study
- •6. Life expectancy is at least 12 months
排除标准
- •1. Patients simultaneously participating in another study
- •2. Previous or concurrent chemotherapy, 5-alpha reductase inhibitor therapy or hormonal therapy specifically for the treatment of prostate cancer other than temporary neo-adjuvant hormonal therapy administered longer than one year prior to study entry
- •3. Development of another invasive neoplastic disease during the previous five years, or concomitant presence of another invasive neoplastic disease, except basal cell carcinoma or squamous cell carcinoma of the skin
- •4. Patients with a history or presence of hepatic or renal disease or other condition known to interfere with metabolism or excretion of drugs
- •5. Patients with a history of alcohol or drug abuse
研究者
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