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)

Bayer HealthCare AG0 个研究点目标入组 806 人开始时间: 2015年8月24日最近更新: 2024年4月15日

适应症

试验速览

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•Histologically or cytologically 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
•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 200

•- Prior cytotoxic chemotherapy for the treatment of CRPC, including taxanes, mitoxantrone and estramustine
•- 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 recovered
•- Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or
•anytime during the 4- week period prior to randomization.

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