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临床试验/EUCTR2012-000142-35-IE
EUCTR2012-000142-35-IE进行中（未招募）1 期

A prospective randomised phase III study of androgen deprivation therapy with or without Docetaxel 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 1,168 人开始时间: 2014年4月10日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
1,168
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
  • •2. Metastatic disease documented by a positive bone scan (any technique) and 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
  • •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, and =80 years old
  • •6. Hematology values:
  • •Hemoglobin = 10.0 g/dL,
  • •Platelet count = 100,000/mL,
  • •Neutrophil = 1500 cells/mm3
  • •7. Biochemistry values:
  • •Renal function: Serum creatinine < 1.5 x ULN or a calculated
  • •creatinine clearance = 60 mL/min,
  • •Serum potassium = 4 mmol/L,
  • •Liver function:
  • •- Serum bilirubin = 1.5 x ULN (except for patients with documented
  • •Gilbert's disease),
  • •- AST and ALT = 1.5 x ULN (and = 5 ULN in case of liver metastases),
  • •ALK-P = 2.5 x ULN (in case of bone metastasis, ALK-P<1000U/L if
  • •bilirubin is normal)
  • •8. Patients must have received ADT for a maximum of 3 months before
  • •randomization and there must be a delay of minimum 6 weeks between
  • •the start of ADT and the start of Docetaxel,
  • •9. Patients willing to receive Docetaxel,
  • •10. Patients might have received previous radiation therapy directed to
  • •bone lesions,
  • •11. Patients able to take oral medication,
  • •12. Patients who have received the information sheet and signed the
  • •informed consent form,
  • •13. Male patients who will receive Docetaxel and/or Abiraterone acetate
  • •and have partners of childbearing potential and/or pregnant partners
  • •must use a method of birth control in addition to an 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
  • •abiraterone acetate and/or for 6 months after the last dose of Docetaxel,
  • •14. Patients must be willing and able to comply with scheduled visits,
  • •treatment plan, laboratory tests and other study procedures,
  • •15. Patients with a public or a private health insurance coverage,
  • •according to local laws for participation in clinical trials.
  • •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 584
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 584

排除标准

  • •1. Patients with previous definitive local treatment directed to the
  • •prostate primary cancer (radiotherapy, brachytherapy, radical
  • •prostatectomy, ultrasound, cryotherapy, or other). A previous transurethral
  • •resection of the prostate (TURP) and previous local treatments
  • •of metastase are allowed,
  • •2. Prior cytotoxic chemotherapy or biological therapy for the treatment
  • •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. Hypertension not controlled by an anti-hypertensive treatment not
  • •modified for more than 3 months (systolic BP = 160 mmHg or diastolic
  • •BP = 95 mmHg; 3 consecutive measures taken 5 minutes apart),
  • •8. Severe or moderate hepatic impairment (Child – Pugh class C or B)
  • •9. Active or symptomatic viral hepatitis or chronic liver disease (except
  • •Gilbert's disease),
  • •10. History of pituitary or adrenal dysfunction,
  • •11. Clinically known significant heart disease in the past 6 months as evidenced by myocardialinfarction, or arterial thrombotic events , severe or
  • •unstable angina, or New York Heart association (NYHA) Class II-IV heart
  • •disease or cardiac ejection fraction measurement of < 50% at baseline,
  • •12. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy,
  • •13. Patient with unstable pulmonary disease (eg. Pulmonary embolism)
  • •14. Pathological finding consistent with small cell carcinoma of the
  • •15. History of malignancy, except non-melanoma skin cancer, with a =
  • •30% probability of recurrence within 24 months,
  • •16. Known allergies, hypersensitivity or intolerance to the study drugs or
  • •excipients,or docetaxel,
  • •17. Administration of an investigational therapeutic within 30 days of
  • •randomization,
  • •18. Patients already included in another therapeutic trial involving an
  • •experimental drug, (patient in a non-experimental trial with no
  • •modification of the patient's care can be included),
  • •19. 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
  • •20. Individual deprived of liberty or placed under the authority of a
  • •21. Patients with impaired vision should undergo a prompt and complete
  • •ophtalmologic examination. Patients with Cystoid Macular Oeadema
  • •cannot be included due to a potential risk of deterioration associated
  • •with docetaxel.
  • •22. Concomitant use of strong CYP3A4 inhibitors ( clarithromyin,
  • •indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin.)

研究者

发起方
ICANCER

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