EUCTR2015-000735-32-PL进行中（未招募）1 期
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects with Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •- Diagnosis of prostate adenocarcinoma as confirmed by the investigator
- •- Metastatic disease documented by greater than or equal to (>=) 1
- •bone lesions on 99mTc bone scan. Participants with a single bone lesion must have confirmation of bone metastasis by computed tomography (CT) or magnetic resonance imaging (MRI)
- •- Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0 or 1
- •- Participants who received docetaxel treatment must meet the following criteria:
- •a) Received a maximum of 6 cycles of docetaxel therapy for mHSPC;
- •b) Received the last dose of docetaxel <=2 months prior to
- •randomization;
- •c) Maintained a response to docetaxel of stable disease or better, by investigator assessment of imaging and PSA, prior to randomization
- •- Other allowed prior treatment for mHSPC:
- •a) Maximum of 1 course of radiation or surgical intervention; radiation therapy for metastatic lesions must be completed prior to
- •randomization;
- •b) Less than or equal to (<=) 6 months of ADT prior to randomization
- •- Allowed prior treatments for localized prostate cancer (all treatments must have been completed >= 1 year prior to randomization)
- •a) <= 3 years total of ADT;
- •b) All other forms of prior therapies including radiation therapy,
- •prostatectomy, lymph node dissection and systemic therapies
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •- Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
- •- Known brain metastases
- •- Lymph nodes as only sites of metastases
- •- Visceral (ie, liver or lung) metastases as only sites of metastases
- •- Other prior malignancy less than or equal to 5 years prior to
- •randomization with the exception of squamous or basal cell skin
- •carcinoma or noninvasive superficial bladder cancer
- •- Prior treatment with other next generation anti-androgens or other CYP17 inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer
- •- History of seizures or medications known to lower seizure threshold
研究者
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