EUCTR2012-002940-26-PL进行中（未招募）1 期
A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
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
- •1. Newly diagnosed metastatic prostate cancer within 3 months prior to
- •randomization with histologically or cytologically confirmed
- •adenocarcinoma of the prostate without neuroendocrine differentiation
- •or small cell histology
- •2. Distant metastatic disease documented by positive bone scan or
- •metastatic lesions on computed tomography or magnetic resonance
- •imaging scan
- •3. At least two of the following high-risk prognostic factors: Gleason
- •score of >=8; presence of 3 or more lesions on bone scan; presence of
- •measurable visceral (excluding lymph node disease) metastasis on CT or
- •MRI scan based on RECIST 1.1
- •4. Eastern Cooperative Oncology Group (ECOG) performance status
- •grade of 0, 1 or 2
- •5. Adequate hematologic, hepatic, and renal function
- •6. Agrees to protocol-defined use of effective contraception
- •Treatment Criteria for Crossover to the Open-label Extension Phase:
- •1. Subject is receiving study drug and is willing and able to provide
- •written informed consent to crossover to open-label abiraterone acetate
- •plus prednisone therapy
- •2. Adequate hepatic and safety laboratory assessments below within 4
- •weeks of OLE Phase Cycle 1 Day 1:
- •total bilirubin =1.5X upper limit of normal (ULN) (except for subjects
- •with documented Gilbert's disease in which case total bilirubin not to
- •exceed 10X ULN)
- •alanine (ALT) and aspartate (AST) aminotransferase =2.5X ULN
- •serum potassium =3.5 mM. If a subject has a serum potassium level
- •<3.5 mM, he could be given adequate potassium supplement and
- •retested. Once the serum potassium level is =3.5 mM after adequate
- •treatment with a potassium supplement, the subject would be eligible
- •for enrollment in the OLE Phase.
- •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 320
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 950
排除标准
- •1. Active infection or other medical condition that would make
- •prednisone use contraindicated
- •2. Any chronic medical condition requiring a higher systemic dose of
- •corticosteroid than 5 mg prednisone per day
- •3. Pathological finding consistent with small cell carcinoma of the
- •4. Known brain metastasis
- •5. Any prior pharmacotherapy, radiation therapy, or surgery for
- •metastatic prostate cancer; the following exceptions are permitted: up to
- •3 months of androgen deprivation therapy (ADT) with lutenizing
- •hormone releasing hormone agonists or orchiectomy with or without
- •concurrent anti-androgens prior to Cycle 1 Day 1; participants may have
- •one course of palliative radiation or surgical therapy to treat symptoms
- •resulting from metastatic disease if it was administered at least 28 days
- •prior to Cycle 1 Day 1, all adverse events associated with these
- •procedures must be resolved at least to Grade 1 by Cycle 1 Day 1.
研究者
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