EUCTR2008-005276-27-BE进行中（未招募）不适用
An Open-Label, Multi-Centre, Randomised, Parallel-Arm One-Year Trial, Comparing the Efficacy and Safety of Degarelix Three-Month Dosing Regimen with Goserelin Acetate in Patients with Prostate Cancer Requiring Androgen Deprivation Therapy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 825
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. 18 years or older.
- •2. Has a histological confirmed prostate cancer Gleason graded).
- •3. Has a screening testosterone above 1.5 ng/mL.
- •4. Rising PSA.
- •5. Has Eastern Cooperative Oncology Group (ECOG) score of = 2.
- •6. Has a life expectancy of at least one year.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Current or previous hormone therapy.
- •2. Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening.
- •3. Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
- •4. Has a heart insufficiency.
- •5. Has a previous history or presence of another malignancy, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last five years.
- •6. Has a clinically significant medical condition (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.
- •7. Has received an investigational drug within the last 28 days before the Screening Visit or longer if considered to possibly influencing the outcome of the current trial.
- •8. Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.
研究者
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