ASP3550 Phase III Study - An Open-Label, Active-Controlled, Parallel-Arm Study, Comparing ASP3550 With Goserelin Acetate in Patients With Prostate Cancer -
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 234
- 主要终点
- Cumulative castration rate of treatment in terms of serum testosterone level
研究概览
简要总结
To compare the efficacy and safety of ASP3550 to goserelin acetate in patients with prostate cancer.
详细描述
This study consists of two parts. The purpose of PART 1 is to test non-inferiority of ASP3550 to goserelin acetate with respect to the cumulative castration rate in terms of serum testosterone when ASP3550 or goserelin acetate is administered for one-year in patients with prostate cancer.
The patients assigned to receive ASP3550 and completed the treatment in PART 1 are eligible for the treatment in PART 2, and will receive ASP3550 maintenance dose subcutaneously for additional term. The long-term safety, efficacy and PK of the continued ASP3550 treatment will be assessed in PART 2.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patient with histologically confirmed prostate cancer (adenocarcinoma).
- •Patient in whom endocrine treatment is indicated. Patient having undergoing prostatectomy or radiotherapy with curative intention and has a rising serum PSA (PSA ≥ 2 ng/mL at screening) may be included.
- •Has a serum testosterone level above 2.2 ng/mL at screening.
- •Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2 at screening.
- •Has a serum PSA ≥ 2 ng/mL at screening.
- •Has a life expectancy of at least 12 months.
排除标准
- •Previous or present endocrine treatment for prostate cancer. Example: surgical castration, GnRH agonists, GnRH antagonists, antiandrogens or oestrogens, and 5α-reductase inhibitors.
- •Received a 5α-reductase inhibitor within 25 weeks preceding screening.
- •Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months.
- •Has concurrent or a history of poorly controlled severe asthma, anaphylactic reactions, severe urticaria or angioedema.
- •Has hypersensitivity towards mannitol.
- •Has a marked prolongation of QT/QTc interval (two consecutive increases to >450 ms in QTc interval at retest) at screening.
- •Has concurrent or a history of a disease (heart failure, hypokalemia, a family history of QT prolongation syndrome, etc.) that may induce Torsade de Pointes.
研究组 & 干预措施
ASP3550 PART 1 and PART 2
Part 1 for 1 year treatment and Part 2 for an extended period of treatment
干预措施: degarelix (Drug)
Goserelin
part 1 for 1 year treatment
干预措施: Goserelin (Drug)
结局指标
主要结局
Cumulative castration rate of treatment in terms of serum testosterone level
时间窗: Up to one year of the treatment
次要结局
- Proportion of castrated subjects in terms of serum testosterone level(Baseline and Days 3, 7, and 28)
- Safety assessed by the incidence of adverse events(up to the end of treatment. approximately for 2 years)
- Changes in serum levels of prostate-specific antigen (PSA) over time(Up to one year of the treatment)