NCT01673984终止4 期
A Phase IV, Randomised, Open-label, Multi-centre Study to Assess the Impact on Disease Control, Safety, Patient and Clinician Experience of Changing Patients With Advanced Prostate Cancer From a 3-monthly LHRH Agonist to 6-monthly Injections of Decapeptyl® SR 22.5 MG
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 27
- 试验地点
- 35
- 主要终点
- Percentage of Participants Maintaining Biochemical Castration
研究概览
简要总结
The purpose of this study is to demonstrate that treatment with a 6-monthly injection of hormone therapy is as good and as well tolerated as the standard 3-monthly hormone therapy injections available for treating prostate cancer. The study will also aim to answer whether both doctors and patients would prefer treatment with a 6-monthly injection rather than injections every 3 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
- •Patients must give written (personally signed and dated) informed consent before completing any study related procedure.
- •Patients must be 18 years old or over.
- •Patients must have a documented diagnosis of locally advanced or metastatic prostate cancer suitable for hormonal treatment
- •Patients must be medically castrated with serum testosterone ≤ 0.5ng/mL
- •Patients must have received at least two injections of a 3- monthly LHRH agonist by the time of the screening tests
- •Patients must be stable on a 3-monthly LHRH agonist injection with stable PSA levels between screening and baseline (i.e. the baseline value must either be lower or less than 25% higher than the Screening value or if ≥25% higher, ≤0.5ng/mL higher than the screening value).
- •In addition:
- •For patients with locally advanced prostate cancer (M0), LHRH agonist injection (any formulation) must have been initiated within the last 3 years from Baseline,
- •For patients with metastatic prostate cancer (M+) and a Gleason score
- •≤ 7, LHRH agonist injection (any formulation) must have been initiated within the last 2 years from Baseline,
- •For patients with metastatic prostate cancer (M+) and a Gleason score > 7, LHRH agonist injection (any formulation) must have been initiated within the last 12 months from Baseline.
- •Patients must have an estimated life expectancy of at least twelve months according to the investigator's assessment.
排除标准
- •Patients have had previous surgical castration or present any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or uncontrolled infection, known pituitary disease).
- •Patients are, in the opinion of the investigator, unable to comply fully with the protocol and the study instructions.
- •Patients have received investigational drug(s) or treatment(s) within 30 days prior to study entry or will require a concurrent treatment with any other experimental drugs or treatments or present any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or uncontrolled infection, known pituitary disease).
- •Patients have had a diagnosis of any other cancer without a history of stability/remission within five years of screening, with the exception of non-metastatic basal cell carcinoma.
- •Patients currently taking additional anti-androgen therapy as part of an active hormonal control therapy.
- •Patients scheduled to receive palliative radiotherapy during the course of the study.
- •Patients receiving an LHRH agonist as neo-adjuvant to radiotherapy or adjuvant to radiotherapy.
- •Patients receiving LHRH agonist as adjuvant to surgery.
- •Patients scheduled to undergo radical prostatectomy during the course of the study.
- •Patients with known hypersensitivity to LHRH agonists, their analogues or any or any other component of the products to be administered.
研究组 & 干预措施
Decapeptyl® SR 22.5mg (Triptorelin)
Experimental
干预措施: Decapeptyl® SR 22.5mg (Drug)
Current 3-monthly LHRH agonist
Active Comparator
One of the following: Decapeptyl® SR 11.25mg (Triptorelin), Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
干预措施: Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg (Drug)
结局指标
主要结局
Percentage of Participants Maintaining Biochemical Castration
时间窗: 6 months
Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.
次要结局
- Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire.(Baseline and Month 12)
- Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)(6 and 12 month)
- Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment.(12 months)
- Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels(6 and 12 months)
- Percentage of Participants Who Changed Injection Frequency After Completion of the Study(Month 12)
- Patient Satisfaction With Treatment.(Month 12)
研究者
研究点 (35)
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