NL-OMON54688已完成3 期
A phase III randomized, double-blind, placebo-controlled trial of radium-223 dichloride in combination with abiraterone acetate and prednisone/prednisolone in the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve subjects with bone predominant metastatic castration-resistant prostate cancer (CRPC) - BAY-88-8223/15396
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Histologically confirmed adenocarcinoma of the prostate
- •- Male subjects of age >= 18 years
- •- Prostate cancer progression documented by prostate specific antigen according
- •to the Prostate Cancer Working Group 2 (PCWG2) criteria or radiological
- •progression according to Response Evaluation Criteria in Solid Tumors (RECIST),
- •version 1.1.
- •- Two or more bone metastases on bone scan within 4 weeks prior to
- •randomization with no lung, liver, other visceral and/or brain metastasis.
- •- Asymptomatic or mildly symptomatic prostate cancer.
- •- Subjects who received combined androgen blockade with an anti-androgen must
- •have shown PSA progression after discontinuing the anti-androgen prior to
- •enrollment.
- •- Medical or surgical castration with testosterone less than 50 ng/dL
- •(1.7nmol/L).
- •- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
排除标准
- •- Prior cytotoxic chemotherapy for the treatment of CRPC, including taxanes,
- •mitoxantrone and estramustine
- •- Administration of immunotherapies (e.g., sipuleucel-T) within 4 weeks before
- •randomization
- •- Any chronic medical condition requiring a higher dose of corticosteroid than
- •5 mg prednisone/prednisolone bid.
- •- Pathological finding consistent with small cell carcinoma of the prostate
- •- History of visceral metastasis, or presence of visceral metastasis detected
- •by screening imaging examinations
- •- History of or known brain metastasis.
- •- Malignant lymphadenopathy exceeding 3 cm in shortaxis diameter.
- •- Blood transfusion or erythropoietin stimulating agents prior 4 weeks of
- •screening and during the whole screening period before randomization
- •- Imminent spinal cord compression based on clinical findings and/or magnetic
- •resonance imaging (MRI).
- •Subjects with history of spinal cord compression should have completely
- •- Use of opiate analgesics for cancer-related pain, including codeine and
- •dextropropoxyphene, currently or
- •anytime during the 4- week period prior to randomization.
研究者
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