EUCTR2008-008604-40-FI进行中（未招募）不适用
A randomised, parallel-arm, open-label trial comparing degarelix with goserelin plus anti-androgen flare protection (bicalutamide), in terms of volume reduction of the prostate in patients with prostate cancer being candidates for medical castration - FE200486 CS31
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
- 180
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. Patient has given written informed consent
- •2. Patient is 18 years or older
- •3. Patient has histologically confirmed prostate cancer
- •4. Patient has a serum PSA level at screening >2 ng/mL
- •5. The prostate size is >30 cubic centimetres (cc), measured by TRUS
- •6. Patient has had a bone-scan within 12 weeks before inclusion
- •7. Patient must be able to undergo transrectal examinations
- •8. Patient has an estimated life expectancy of at least 12 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. Any previous treatments for prostate cancer
- •2. Previous trans-urethral resection of the prostate (TURP)
- •3. Is not considered a candidate for medical castration
- •4. Use of urethral catheter
- •5. Is currently treated with a 5-alpha reductase inhibitor
- •6. Is currently treated with an alpha-adrenoceptor antagonist
- •7. Treatment with botulinum toxin A (Botox)
- •8. Require radiotherapy during the trial
- •9. History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema
- •10. Hypersensitivity towards any component of the investigational products or excipients
- •11. Previous history or presence of another malignancy
- •12. A clinically significant disorder
- •13. A corrected QT interval over 450 msec
- •14. Mental incapacity or language barrier precluding adequate understanding or co-operation
- •15. Receipt of an investigational drug within the last 28 days proceeding screening
- •16. Previous participation in any degarelix trial
研究者
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