Last updated on January 2019

A Phase III of ADT + Docetaxel +/- Local RT +/- Abiraterone Acetate in Metastatic Hormone-na ve Prostate Cancer


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Metastatic Prostate Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male

Inclusion criteria:

  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 can be included if they have either:
    • At least one extra-pelvic lymph node 2 cm or
    • 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 (PS 2 due to bone pain accepted),
  4. Life expectancy 6 months,
  5. Male aged 18 years old,
  6. Hemoglobin 10.0 g/dL,
  7. Platelet count 100,000/L,
  8. Serum creatinine < 1.5 x ULN or calculated creatinine clearance 60 mL/min,
  9. Serum potassium 4.0 mmol/L,
  10. Serum bilirubin 1.5 x ULN (except documented Gilbert's disease); AST and ALT 1.5 x ULN ( 5 ULN in case of liver metastases), ALP 2.5 x ULN
  11. Patients might have received a maximum of 3 months of ADT before randomization,
  12. Patients might have received previous radiation therapy directed to bone lesions
  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,
  18. Patients willing to receive docetaxel
  19. Neutrophil 1500 cells/mm3
  20. Male patients who have partners of childbearing potential and/or pregnant partners are advised to 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 6 months after the last dose of docetaxel.

Exclusion Criteria:

  1. Patients with previous local treatment directed to the prostate primary cancer. A previous TURP is allowed,
  2. Prior cytotoxic chemotherapy or biological therapy for the treatment of prostate cancer,
  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 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 within 4 weeks of randomization,
  7. Uncontrolled hypertension (systolic BP 160 mmHg or diastolic BP 95 mmHg),
  8. Patients with a history of hypertension except if 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. Small cell carcinoma of the prostate,
  12. Clinically known significant heart disease (myocardial infarction, arterial thrombotic events in the past 6 months, severe or unstable angina,NYHA Class II-IV heart disease or cardiac EF < 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 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 participation,
  19. Individual deprived of liberty or placed under the authority of a tutor.

Additional criteria for patients receiving docetaxel:

21. Patients with impaired vision should undergo a prompt and complete ophthalmologic examination. In case of Cystoid Macular Oeadema, the patient should not receive docetaxel.

22. Concomitant use of strong CYP3A4 inhibitors ( clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin) 23. Allergy to taxane

Recruitment Status: Closed


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