A prospective randomised phase III study of androgen deprivation therapy with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.

ICANCER0 个研究点目标入组 916 人开始时间: 2013年5月22日最近更新: 2014年6月30日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 916

研究概览入排标准研究者记录与标识符相似试验

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. Histologically or cytologically confirmed adenocarcinoma of the prostate,
•2. Metastatic disease documented by positive bone scan or CTscan or MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (pelvic lymph nodes located below the iliac bifurcation) can be included if they have either:
•o At least one extra-pelvic lymph node = 2 cm
•o extra-pelvic lymph node (s) = 1 cm if the patients also have at least one pelvic lymph node = 2 cm
•3. Patients with ECOG = 1 (patient with PS 2 due to bone pain can be accrued in the trial),
•4. Life expectancy of at least 6 months,
•5. Male aged = 18 years old,
•6. Hemoglobin = 10.0 g/dL,
•7. Platelet count = 100,000/µL,
•8. Renal function: serum creatinine < 1.5 x ULN or a calculated creatinine clearance = 60 mL/min,
•9. Serum potassium > 3.5 mmol/L,
•10. Liver function: Serum bilirubin = 1.5 x ULN (except for patients with documented Gilbert’s disease); AST and ALT = 2.5 x ULN (and = 5 ULN in case of liver metastases),
•11. Patients might have received a maximum of 3 months of androgen deprivation therapy (ADT) before randomization,
•12. Patients might have received previous radiation therapy directed to bone lesions, as far as it is terminated by the time of randomization,
•13. Patients able to take oral medication,
•14. Patients who have received the information sheet and signed the informed consent form,
•15. Male patients who are receiving the study treatment and have partners of childbearing potential are advised to use a method of birth control with adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of the study treatment,
•16.Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,
•17.Patients with a public or a private health insurance coverage,
•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 458
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 458

排除标准

•1. Patients with previous local treatment directed to the prostate primary cancer (radiotherapy, brachytherapy, radical prostatectomy, or other). A previous trans-urethral resection of the prostate (TURP) is allowed,
•2. Prior cytotoxic chemotherapy or biological therapy for the treatment of CRPC,
•3. Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone twice daily,
•4. Active infection or other medical condition for which prednisone/prednisolone (corticosteroid) use would be contraindicated,
•5. Previously treated with ketoconazole for prostate cancer for more than 7 days,
•6. Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of randomization,
•7. Uncontrolled hypertension (systolic BP = 160 mmHg or diastolic BP = 95 mmHg),
•8. Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment,
•9. Active or symptomatic viral hepatitis or chronic liver disease (except Gilbert’s disease),
•10. History of pituitary or adrenal dysfunction,
•11. Pathological finding consistent with small cell carcinoma of the prostate,
•12. Clinically known significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline,
•13. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy,
•14. Other malignancy, except non-melanoma skin cancer, with a = 30% probability of recurrence within 24 months,
•15. Known allergies, hypersensitivity or intolerance to the study drugs or excipients,
•16. Administration of an investigational therapeutic within 30 days of M1 D1,
•17. Patients already included in another therapeutic trial involving an experimental drug,
•18. Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition which, in the opinion of the investigator, would preclude participation in this trial. Those conditions should be discussed with the patient before registration in the trial,
•19. Individual deprived of liberty or placed under the authority of a tutor.

研究者

发起方

ICANCER

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