EUCTR2008-003931-19-IT进行中（未招募）不适用
An open-label, multi-centre, uncontrolled, trial investigating Degarelix one-month dosing regimenadministered as Intermittent Androgen Deprivation (IAD) for one cycle in patients with prostate cancer requiring androgen deprivation therapy. - FE200486CS29
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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. Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient 2. Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages), and is in need of androgen deprivation treatment 3. A. Patients with Locally Advanced or Metastatic Prostate Cancer Screening PSA level (measured at a central laboratory) must be >4 ng/mL and ≤50 ng/mL 3. B. Patients with Localised Prostate Cancer or Patients with Previous Therapy with Curative Intention and a Rising PSA PSA doubling time (based on patient records at the trial site) must be <24 months. There is no minimum PSA level required and the maximum PSA must be ≤50 ng/mL. 4. Is a male patient aged 18 years or older 5. Has an ECOG (Eastern Cooperative Oncology Group) score of ≤2 6. Has a life expectancy of at least 24 months
- •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. Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, 5-alpha reductase inhibitors). However, for patients having undergone prostatectomy or radiotherapy with curative intention, then neoadjuvant/adjuvant hormonal therapy for a maximum duration of 6 months is accepted. This treatment should have been terminated at least 6 months prior to Screening Visit 2. Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy 3. Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema 4. Has hypersensitivity towards any component of the investigational medicinal product 5. Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin 6. Has a known or suspected clinically significant liver and/or biliary disease 7. Has any clinically significant laboratory abnormalities which in the judgment of the investigator would affect the patient?s health or the outcome of the trial 8. Has a clinically significant disorder (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 9. Has a mental incapacity or language barriers precluding adequate understanding or co operation 10. Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial 11. Has previously participated in any degarelix trial
研究者
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