A Randomised, Parallel-arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Reduction in International Prostate Symptom Score (IPSS), in Patients With Lower Urinary Tract Symptoms (LUTS) Secondary to Locally Advanced Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 32
- 主要终点
- Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12
研究概览
简要总结
The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a standard drug hormonal treatment worked on the same symptoms. The advancement/worsening of prostate cancer may be associated with LUTS and the symptoms may impact the ability to urinate normally and thereby the quality of life for these patients.
Patients were randomly selected (like flipping a coin) to receive either degarelix or standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment period. During this period the relief of urinary symptoms was evaluated via a questionnaire filled in by patients and addressing the severity and frequency of their symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient has given written informed consent before any trial-related activity is performed
- •Has a confirmed prostate cancer in which this type of treatment is needed.
排除标准
- •Previous treatment for prostate cancer
- •Previous trans-urethral resection of the prostate
- •Current use of 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
- •Patients in need of external beam radiotherapy to be started at the same time as hormone therapy
- •Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
- •History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
- •Hypersensitivity towards any component of the investigational product
- •Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
- •Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.
研究组 & 干预措施
Degarelix 240 mg/80 mg
Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
干预措施: Degarelix (Drug)
Goserelin (3.6 mg) + bicalutamide (50 mg)
Goserelin (3.6 mg) + bicalutamide (50 mg)
干预措施: Goserelin (Drug)
Goserelin (3.6 mg) + bicalutamide (50 mg)
Goserelin (3.6 mg) + bicalutamide (50 mg)
干预措施: Bicalutamide (Drug)
结局指标
主要结局
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12
时间窗: After treatment of 12 weeks compared to Baseline
The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.
次要结局
- Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit(After treatment of 4, 8 and 12 weeks compared to Baseline)
- Change From Baseline in Residual Volume (Vresidual) at Each Visit(After treatment of 4, 8 and 12 weeks compared to Baseline)
- Change From Baseline in Total IPSS at Weeks 4 and 8(After treatment of 4 and 8 weeks compared to Baseline)
- Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12(After 12 weeks treatment compared to Baseline)
- Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit(After treatment of 4, 8 and 12 weeks compared to Baseline)
- Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit(After treatment of 4, 8 and 12 weeks compared to Baseline)
- Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit(After treatment of 4, 8 and 12 weeks compared to Baseline)
- Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables(Baseline to 12 weeks of treatment)
- Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight(Baseline to 12 weeks of treatment)