Inclusion Criteria

Inclusion criteria:

- Metastatic Hormone Refractory Prostate Cancer (mHRPC) previously treated with a
docetaxel-containing regimen

- Disease Progression during or after docetaxel-containing regimen for mHRPC

- Surgical or medical castration

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-2

- Life-expectancy ≥3 months

- Adequate bone marrow, liver, and renal function: Neutrophils> 1500 /mm3; Hemoglobin >
10 g/dL; Platelets > 100 x109/L; Bilirubin < ULN; SGOT (AST) < 1.5xULN; SGPT (ALT) <
1.5xULN; Creatinine < 1.5xULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance
will be calculated according to CKD-EPI formula and patients with creatinine
clearance < 60 mL/min should be excluded.

Exclusion criteria:

- Prior radiotherapy to ≥ 40% of bone marrow

- Prior radionuclide therapy (samarium-153, strontium-89, P-32…)

- Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks
prior to enrollment

- Active grade ≥2 peripheral neuropathy

- Active grade ≥2 stomatitis

- Active infection requiring systemic antibiotic or anti-fungal medication

- Active cancer (other than mHRPC) including prior malignancy from which the patient
has been disease-free for ≤5 years (except superficial basal cell skin cancer)

- Known brain or leptomeningeal involvement

- History of severe hypersensitivity reaction (≥grade 3) to docetaxel

- History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing
drugs

- History of severe hypersensitivity reaction (≥grade 3) or intolerance to prednisone
or prednisolone

- Uncontrolled severe illness or medical condition (including uncontrolled cardiac
arrhythmias, angina pectoris, hypertension or diabetes mellitus). History of
congestive heart failure (NYHA III or IV) or myocardial infarction within last 6
months is also not allowed.

- Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450
3A4/5

- Participation in a clinical trial with any investigational drug

- Patient with reproductive potential not implementing accepted and effective method of
contraception

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.