Inclusion Criteria

Inclusion criteria :

- Histologically proven Castration-Resistant Prostate Cancer (stage IV only);

- Prior failure of treatment with docetaxel; o Documentation of metastasis by imaging.

- Performance status 0 or 1;

Exclusion criteria:

- Previous treatment with chemotherapy, except for docetaxel;

- Previous use of abiraterone;

- Inability to maintain treatment with androgen deprivation if no previous history of
orchiectomy;

- Presence of any other active malignancy or history of any tumor diagnosed in the last
5 years, except basal cell or squamous cell carcinoma of the skin or in situ
carcinoma of the skin, bladder or anal canal (these tumors do not prevent
participation if they have been treated, even in the last 5 years);

- Hypersensitivity or known allergy to any of the treatments under study, including
history of severe hypersensitivity reaction (≥grade 3) to docetaxel and/or to
polysorbate 80 containing drugs

- History of congestive heart failure or myocardial infarction within the last 6
months, or uncontrolled cardiac arrhythmias, angina pectoris or uncontrolled
hypertension;

- Uncontrolled severe illness or medical condition (including uncontrolled diabetes
mellitus)

- Presence of severe comorbidity, which in the opinion of the investigator, puts the
patient at risk or impairs compliance to the protocol;

- Known seropositivity for HIV;

- Presence of significant psychiatric or neurological disease, in the investigator's
opinion;

- Presence of uncontrolled hypercalcemia;

- Refusal to use appropriate contraception during the study period;

- Participation in any clinical trial in the last 12 months, unless there is benefit to
the patient to be justified by the principal investigator

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

- Inadequate organ and bone marrow function

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