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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 46
- 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
This was a Phase 3b clinical study in prostate cancer patients which aimed to compare the current standard therapy of a gonadotrophin releasing hormone (GnRH) agonist, goserelin (3.6 mg; plus anti-androgen flare protection, bicalutamide), to a novel GnRH antagonist, degarelix (240 mg starting dose/80 mg maintenance dose) with respect to mean percentage reduction in prostate volume.
The hypothesis was that degarelix could decrease prostate size at least as effectively as the combination of a GnRH agonist with an anti-androgen for flare protection.
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
- •Patient is 18 years or older
- •Patient has histologically confirmed prostate cancer
- •Patient has a serum prostate-specific antigen (PSA) level at screening >2 ng/mL
- •The prostate size is >30 cubic centimetres (cc), measured by TRUS
- •Patient has had a bone-scan within 12 weeks before inclusion
- •Patient must be able to undergo transrectal examinations
- •Patient has an estimated life expectancy of at least 12 months
排除标准
- •Any previous treatments for prostate cancer
- •Previous trans-urethral resection of the prostate (TURP)
- •Is not considered a candidate for medical castration
- •Use of urethral catheter
- •Is currently treated with a 5-alpha reductase inhibitor
- •Is currently treated with an alpha-adrenoceptor antagonist
- •Treatment with botulinum toxin A (Botox)
- •Require radiotherapy during the trial
- •History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema
- •Hypersensitivity towards any component of the investigational products or excipients
- •Previous history or presence of another malignancy
- •A clinically significant disorder
- •A corrected QT interval over 450 msec
- •Mental incapacity or language barrier precluding adequate understanding or co-operation
- •Receipt of an investigational drug within the last 28 days proceeding screening
- •Previous participation in any degarelix trial
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)
Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin.
干预措施: Goserelin (Drug)
Goserelin (3.6 mg) + bicalutamide (50 mg)
Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin.
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 in Serum Testosterone Levels During the Study(At 4, 8, and 12 weeks compared to baseline.)
- Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study(At 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)
- Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII)(After treatment of 4, 8, and 12 weeks compared to Baseline)
- Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8(After treatment of 4 and 8 weeks compared to Baseline)
- 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)
- 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)