Randomised Phase 3 Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,125
- 试验地点
- 82
- 主要终点
- Overall Survival Time
研究概览
简要总结
The purpose of this study is to determine the effectiveness of enzalutamide, versus a conventional non-steroidal anti androgen (NSAA), when combined with a luteinizing hormone releasing hormone analog (LHRHA) or surgical castration, as first line androgen deprivation therapy (ADT) for newly diagnosed metastatic prostate cancer.
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
- 未提供
排除标准
- •Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
- •seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma).
- •loss of consciousness or transient ischemic attack within 12 months of randomization
- •significant cardiovascular disease within the last 3 months including: myocardial infarction, unstable angina, congestive heart failure, ongoing arrhythmias of Grade >2 [National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.03], thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism). Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
- •Life expectancy of less than 12 months.
- •History of another malignancy within 5 years prior to randomisation, except for either non- melanomatous carcinoma of the skin or, adequately treated, non-muscle-invasive urothelial carcinoma of the bladder (Tis, Ta and low grade T1 tumours).
- •Concurrent illness, including severe infection that might jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
- •a. Human Immunodeficiency Virus (HIV)-infection is not an exclusion criterion if it is controlled with anti-retroviral drugs that are unaffected by concomitant enzalutamide.
- •Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse;
- •Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception.
- •Prior ADT for prostate cancer (including bilateral orchidectomy), except in the following settings:
- •Started less than 12 weeks prior to randomisation AND Prostate Specific Antigen (PSA) is stable or falling. The 12 weeks starts from whichever of the following occurs earliest: first dose of oral anti- androgen, LHRHA, or surgical castration.
- •In the adjuvant setting, where the completion of adjuvant hormonal therapy was more than 12 months prior to randomisation AND the total duration of hormonal treatment did not exceed 24 months. For depot preparations, hormonal therapy is deemed to have started with the first dose and to have been completed when the next dose would otherwise have been due, e.g. 12 weeks after the last dose of depot goserelin 10.8mg.
- •Prior cytotoxic chemotherapy for prostate cancer, but up to 2 cycles of docetaxel chemotherapy for metastatic disease is permitted.
- •Participation in other clinical trials of investigational agents for the treatment of prostate cancer or other diseases.
研究组 & 干预措施
Enzalutamide
Enzalutamide is 160 mg daily, by mouth, until clinical disease progression or prohibitive toxicity.
All participants are to receive standard background therapy with a LHRHA or surgical castration, as per standard of care. The choice of the LHRHA or surgical castration is at the discretion of the treating clinician.
干预措施: Enzalutamide (Drug)
Enzalutamide
Enzalutamide is 160 mg daily, by mouth, until clinical disease progression or prohibitive toxicity.
All participants are to receive standard background therapy with a LHRHA or surgical castration, as per standard of care. The choice of the LHRHA or surgical castration is at the discretion of the treating clinician.
干预措施: LHRHA or Surgical Castration (Drug)
Conventional NSAA
Conventional NSAA, by mouth until clinical disease progression or prohibitive toxicity.
All participants are to receive standard background therapy with a LHRHA or surgical castration, as per standard of care. The choice of the LHRHA or surgical castration is at the discretion of the treating clinician.
干预措施: NSAA (Drug)
Conventional NSAA
Conventional NSAA, by mouth until clinical disease progression or prohibitive toxicity.
All participants are to receive standard background therapy with a LHRHA or surgical castration, as per standard of care. The choice of the LHRHA or surgical castration is at the discretion of the treating clinician.
干预措施: LHRHA or Surgical Castration (Drug)
结局指标
主要结局
Overall Survival Time
时间窗: 3 years
the interval from the date of randomisation to date of death.
次要结局
- Adverse events(3 years)
- Healthcare resource cost-effectiveness (incremental cost effectiveness ratio)(3 years)
- Clinical progression free survival time(3 years)
- Health-related quality of life (EORTC Core Quality of Life Questionnaire (QLQ C-30), Quality of Life Questionnaire for Prostate Cancer (PR-25), Euroqol 5 item preference-based measure of health (EQ-5 D-5L))(3 years)
- Prostate specific antigen progression free survival time(3 years)