Patient Preference Between Cabazitaxel and Docetaxel in Metastatic Castrate-resistant Prostate Cancer

• Affiliated to a social security regimen ;
• Male patients older than 18 years ;
• Histologically confirmed adenocarcinoma of the prostate ;
• Continued androgen deprivation therapy either by LHRH agonists/antagonists or orchidectomy ;
• Serum testosterone \<0.50 ng/ml (1.7 nmol/L) ;
• Progressive disease (PSA progression or radiological progression or clinical progression) ;
• ECOG 0-2 ;
• Information delivered to patient and informed consent form signed by the patient or his legal representative ;

• Adequate organ or bone marrow function as evidenced by:

  • Hemoglobin >/= 10 g/dL
  • Absolute neutrophil count >/=1.5 x 109/L,
  • Platelet count >/=100 x 109/L,
  • AST/SGOT and/or ALT/SGPT \</=1.5 x ULN;
  • Total bilirubin \</=1.5 x ULN,
  • Serum creatinine \</=1.5 x ULN. If creatinine 1.0 - 1.5 xULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance \<60 mL/min should be excluded

Exclusion Criteria:

• Patients having received an investigational drug and/or prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior enrolment in the study, excepted radiotherapy directed to a single bone lesions which is nonacceptable if within 2 weeks ;
• Prior treatment with Taxotere or Jevtana ;
• Pre-existing symptomatic peripheral neuropathy grade > 2 (CTCAE V4) ;
• Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months is also not allowed ;
• History of severe hypersensitivity reaction (grade ≥3) to polysorbate 80 containing drugs ;
• Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus), active infection including HIV infection, active Hepatitis B or C infection that would preclude participation in the trial ;
• Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) ;