A Phase IV Interventional Safety Study of ELIGARD® in Prostate Cancer Patients in Asia (ELIGANT)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 19
- 主要终点
- Number of Participants With Eligard Related Adverse Events (AE)
研究概览
简要总结
The objective of this study was to evaluate the safety profile of ELIGARD® in ethnic Asian prostate cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •A patient for whom the physician has decided to initiate treatment with a Luteinizing Hormone Releasing Hormone (LHRH) agonist in standard clinical practice
- •Biopsy-proven prostate adenocarcinoma
- •Locally advanced prostate cancer with biochemical relapse radical prostatectomy and/or radiotherapy, OR hormonal treatment-naive advanced or metastatic prostate cancer patient who has not received chemotherapy and has no plans to undergo treatment with chemotherapy at study entry.
- •Patient who indicates that once the study is completed, he expects having access to androgen deprivation therapy (ADT), either medical or surgical, within the local healthcare system (either through public/ private health insurance or out of pocket payment).
排除标准
- •Patient with castrate resistant prostate cancer
- •Patient who previously underwent bilateral orchiectomy
- •Patient who has received prior treatment with LHRH analogues
- •Prior or concomitant treatment with systemic chemotherapy. A patient where there is a likelihood to receive systemic chemotherapy should not be enrolled
- •Life expectancy of < 1 year due to comorbidities
- •Participation in another interventional clinical trial within one month prior to study entry or during the duration of the study
- •Patient who plans to receive intermittent ADT at the time of study entry
- •Patient receiving non-palliative radiotherapy within 3 months prior to study entry
- •Patient receiving adjuvant ADT in combination with definitive radiotherapy
- •Patient with metastatic hormonal treatment-naive prostate cancer, for whom chemo-hormonal treatment (combination of Docetaxel and ADT) is indicated.
- •Patient with hypersensitivity to gonadotropin releasing hormone (GnRH), GnRH agonist analogs or any of the components of ELIGARD®
- •Patient with any contraindication for ELIGARD® use based on local prescribing information
研究组 & 干预措施
Leuprolide Acetate 22.5 milligrams (mg)
Participants received 22.5 mg of leuprolide acetate (eligard) by subcutaneous injection at baseline, month 3, 6, 9, 12 and 15.
干预措施: Leuprolide (Drug)
结局指标
主要结局
Number of Participants With Eligard Related Adverse Events (AE)
时间窗: From first dose of study drug up to 18 months
An AE was defined as any untoward medical occurrence in a participant administered a study drug or had undergone study procedures that did not necessarily have a causal relationship with this treatment. An AE was considered to be serious if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required inpatient hospitalization or led to prolongation of hospitalization, other medically important events. Drug-related AEs are AEs where causal relationships were at least a reasonable possibility as determined by the investigator.
次要结局
- Percentage of Participants With Testosterone Levels Less Than (<) 20, 20-50 and Greater Than (>) 50 Nanogram Per Deciliter (ng/dL) at Month 12(Month 12)
- Percentage of Participants With Testosterone Levels < 20, 20-50 and > 50 ng/dL at Month 18(Month 18)
- Time to PSA Progression(From first dose of study drug up to PSA progression (18 months))
- Percentage of Participants With Greater Than or Equal to (≥) 30% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18(Months 3, 6, 9, 12, 15 and 18)
- Percentage of Participants With ≥50% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18(Months 3, 6, 9, 12, 15 and 18)
- Percentage of Participants With ≥90% PSA Percent Reduction From Baseline at Month 3, 6, 9, 12, 15, and 18(Months 3, 6, 9, 12, 15 and 18)
- Change From Baseline in EQ-5D-5L Health State Utility Index Score (Japan) at Months 6, 12 and 18(Baseline, months 6, 12 and 18)
- Change From Baseline in EQ-5D-5L Health Status Utility Index Score (UK) at Months 6, 12 and 18(Baseline, months 6, 12 and 18)
- Change From Baseline in EQ-5D-5L Health Status Utility Index Score (US) at Months 6, 12 and 18(Baseline, months 6, 12 and 18)
- Change From Baseline in EQ-5D02-EQ-VAS Score at Months 6, 12 and 18(Baseline, months 6, 12 and 18)
- Change From Baseline in EORTC QLQ-PR25 Score at Months 6, 12 and 18(Baseline, months 6, 12 and 18)