EUCTR2012-002940-26-PT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
- 1,270
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
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 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 prostate
- •3. Known brain metastasis
- •4. 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.
- •5. Uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic BP >=95 mmHg; patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment)
- •6. Active or symptomatic viral hepatitis or chronic liver disease, ascites or bleeding disorders secondary to hepatic dysfunction.
- •7. History of adrenal dysfunction
- •8. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events or history of cardiac failure in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease
- •9. Atrial fibrillation, or other cardiac arrhythmia requiring pharmacotherapy
- •10. Other malignancy (within 5 years), except non-melanoma skin cancer
- •11. Administration of an investigational therapeutic or invasive surgical procedure (not including surgical castration) within 28 days of Cycle 1 Day 1 or currently enrolled in an investigational study
- •12. Any condition or situation which, in the opinion of the investigator, would put the patient at risk, may confound study results, or interfere with the patient’s participation in this study
研究者
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