A Randomised, Parallel Arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Prostate Size Reduction in Prostate Cancer Patients of Intermediate-to-high Risk, Who Require Neoadjuvant Hormone Therapy Prior to Radiotherapy (Curative Intent)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 66
- 主要终点
- Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)
研究概览
简要总结
The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.
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
- •Patients who are lymph node positive or have other metastatic disease
- •Use of urethral catheter
- •Current treatment with a 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
- •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.
- •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)
- •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
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
干预措施: Degarelix (Drug)
Goserelin (3.6 mg) + bicalutamide (50 mg)
On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).
On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
干预措施: Goserelin (Drug)
Goserelin (3.6 mg) + bicalutamide (50 mg)
On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).
On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
干预措施: Bicalutamide (Drug)
结局指标
主要结局
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)
时间窗: After treatment of 12 weeks compared to Baseline
TRUS is a method of measuring the size of the prostate.
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)
时间窗: After treatment of 12 weeks compared to Baseline
TRUS is a method of measuring the size of the prostate.
次要结局
- Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12(After treatment of 4, 8, and 12 weeks compared to Baseline)
- Change From Baseline in Serum Testosterone Levels During the Study(After treatment of 4, 8, and 12 weeks compared to Baseline)
- Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study(After treatment of 4, 8, and 12 weeks compared to Baseline)
- Change From Baseline in Serum Oestradiol Levels During the Study(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 Vital Signs and Body Weight(Baseline to 12 weeks of treatment)
- Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables(Baseline to 12 weeks of treatment)