A Multi-centre, Prospective, Observational Study on Effectiveness and Safety of ZOLADEX® (Goserelin Acetate Implant) 10.8 mg and ZOLADEX® (Goserelin Acetate Implant) 3.6 mg in Chinese Patients With Localized or Locally Advanced Hormonal Treatment -naïve Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- PSA level
研究概览
简要总结
This study is a multi-centre, prospective observational study. The study plans to enrol 500 patients with localized or locally advanced prostate cancer who are eligible and intended to be prescribed Zoladex® (goserelin acetate implant) 10.8 mg or Zoladex® (goserelin acetate implant) 3.6 mg as monotherapy or in combination with androgen blockade (CAB) at 50 clinical sites in China. The effectiveness and safety data will be collected at baseline and each visit within 26 weeks after treatment of Zoladex®.
详细描述
Androgen Deprivation Therapy (ADT) is a standard treatment for locally advanced or metastatic prostate cancer. It is also increasingly used in patients with high-risk localized prostate cancer or in patients with prostate-specific antigen (PSA) relapse after local therapy.
The luteinizing hormone-releasing hormone (LHRH) agonists, such as goserelin acetate(Zoladex®), have provided an effective and reversible means of suppressing androgen level. Zoladex® was originally formulated as a 3.6mg depot injection. Goserelin acetate 10.8-mg depot, given once every 3 months, is pharmacodynamically equivalent to 3 consecutive monthly injections of the goserelin acetate 3.6-mg depot, offers a more convenient and cost-effective dosing regimen for patients.
Goserelin acetate 10.8-mg depot has been available in China since 2012. However, data on the effectiveness and safety of the long-acting depot of Zoladex® (goserelin acetate depot) 10.8mg specifically in a Chinese population is limited. A "real-world" observational study is proposed to establish the effectiveness and safety profile of Zoladex ® 10.8mg in Chinese patients with localized or locally advanced prostate cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Ability to provide informed consent, complete all study assessments and have complete medical record;
- •Male aged 18 years and over;
- •Diagnosis of localized or locally advanced prostate cancer requiring immediate hormonal therapy;
- •Being prescribed Zoladex ® (goserelin acetate implant) 10.8 mg or Zoladex ® (goserelin acetate implant) 3.6 mg in accordance with the terms of marketing authorization as monotherapy or in combination with androgen blockade (CAB);
- •More than 26 weeks' life expectancy;
排除标准
- •Patients who are planned to receive radiation therapy;
- •Patients with hypersensitivity to LHRH, its analogues, or any components of goserelin depot;
- •Previous or concurrent hormonal therapy including surgical castration, androgen blockers, oestrogen therapy, or other LHRH agonists.
结局指标
主要结局
PSA level
时间窗: each visit within 26 weeks during treatment
Change from baseline in PSA level at each visit within 26 weeks during treatment
Serum Testosterone
时间窗: each visit within 26 weeks during treatment
Change from baseline in the serum Testosterone at each visit within 26 weeks during treatment
次要结局
- Incidence of Serious Adverse Events (SAEs)(each visit within 26 weeks during treatment)
- Incidence of Adverse Drug Reactions (ADRs)(each visit within 26 weeks during treatment)
- Number of patients with serum Testosterone less than 50 ng/ml(each visit within 26 weeks during treatment)
- Proportion of patients with serum Testosterone less than 50 ng/ml(each visit within 26 weeks during treatment)
- Mean serum PSA level(each visit within 26 weeks during treatment)
- Incidence of AEs leading to treatment discontinuation(each visit within 26 weeks during treatment)
- Mean serum Testosterone level(each visit within 26 weeks during treatment)
- Incidence of Adverse Events (AEs)(each visit within 26 weeks during treatment)
- Incidence of AESI (cardiovascular related AE, sexual related AE)(each visit within 26 weeks during treatment)