NCT02200614已完成3 期
A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,509
- 主要终点
- Metastasis-Free Survival
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.
- •Castration-resistant prostate cancer (CRPC) with castrate level of serum testosterone.
- •Prostate-specific Antigen (PSA) doubling time of ≤ 10 months and PSA > 2ng/ml.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Blood counts at screening: haemoglobin ≥ 9.0 g/dl,absolute neutrophil count ≥ 1500/µl, platelet count ≥ 100,000/µl.
- •Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, creatinine ≤ 2.0 x ULN.
- •Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment.
排除标准
- •History of metastatic disease at any time or presence of detectable metastases.
- •Acute toxicities of prior treatments and procedures not resolved to grade ≤ 1 or baseline before randomisation.
- •Prior treatment with: second generation androgen receptor (AR) inhibitors, other investigational AR inhibitors, or CYP17 enzyme inhibitor.
- •Use of estrogens or 5-α reductase inhibitors or AR inhibitors.
- •Prior chemotherapy or immunotherapy for prostate cancer.
- •Use of systemic corticosteroid.
- •Radiation therapy within 12 weeks before randomisation.
- •Severe or uncontrolled concurrent disease, infection or co-morbidity.
- •Treatment with bisphosphonate or denosumab within 12 weeks before randomisation.
- •Known hypersensitivity to the study treatment or any of its ingredients.
- •Major surgery within 28 days before randomisation.
- •Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.
- •Uncontrolled hypertension.
- •Prior malignancy.
- •Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.
- •Active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease.
- •Treatment with any investigational drug within 28 days before randomisation.
- •Any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures.
研究组 & 干预措施
Darolutamide (BAY1841788)
Experimental
Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
干预措施: Darolutamide (Nubeqa, BAY1841788) (Drug)
Placebo
Placebo Comparator
Participants received matching placebo 2 tablets twice daily with food.
干预措施: Placebo (Drug)
结局指标
主要结局
Metastasis-Free Survival
时间窗: From randomization to the time approximately 385 MFS events were observed (approximately 48 months)
Metastasis-Free Survival (MFS) is defined as the time from randomisation to evidence of metastasis or death from any cause, whichever occurs first (cut-off date 15 Nov 2019)
次要结局
- Time to Pain Progression - Final Analysis(From randomization until last study treatment (assessed every 4 months) (approximately 48 months))
- Overall Survival - Primary Analysis(From randomization of the first subject to the time approximatively 140 death events were observed (approximately 48 months))
- Overall Survival - Final Analysis(From randomization of the first subject to the time approximatively 254 death events were observed (approximately 56 months))
- Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Final Analysis(From randomization until initiation of first cytotoxic chemotherapy treatment (approximately 59 months))
- Time to First Symptomatic Skeletal Event (SSE) - Primary Analysis(From randomization until last study treatment (assessed every 4 months) (approximately 48 months))
- Time to Pain Progression - Primary Analysis(From randomization until last study treatment (assessed every 4 months) (approximately 48 months))
- Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Primary Analysis(From randomization until last study treatment (assessed every 4 months) (approximately 48 months))
- Time to First Symptomatic Skeletal Event (SSE) - Final Analysis(From randomization until occurrence of first SSE event (approximately 59 months))
研究者
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