EUCTR2008-008604-40-PT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 before any trial-related activity is performed
- •2.Patient is 18 years or older
- •3. Patient has histologically confirmed prostate cancer (Gleason graded, all stages; T3 or T4, any N, any M) and endocrine treatment is indicated
- •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.Patients 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. If the patient has been treated with a 5-alpha reductase inhibitor the treatment must have stopped at least 6 months prior to this trial
- •6.Is currently treated with an alpha-adrenoceptor antagonist. If the patient has been treated with an alpha-adrenoceptor antagonist the treatment must have stopped at least 8 weeks prior to this trial
- •7.Treatment with botulinum toxin A (Botox) for enlarged prostate within the last 6 months
- •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, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last 5 years
- •12. 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
- •13.A corrected QT interval (using the Fridericia correction method) 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 or longer if considered to possibly influence the outcome of the current trial
- •16.Previous participation in any degarelix trial
研究者
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