Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen

Inclusion Criteria

Inclusion criteria :

I 01. Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that is
resistant to hormone therapy and previously treated with a docetaxel-containing regimen.

I 02. Patient must have either measurable or non-measurable disease. I 03. Received prior
castration by orchiectomy and/or Luteinizing Hormone-Releasing Hormone (LH-RH) agonist
with or without antiandrogen, antiandrogen withdrawal, monotherapy with estramustine, or
other hormonal agents.

I 04. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2 (ie, patient
must be ambulatory, capable of all self-care, and up and about more than 50% of waking
hours).

I 05. Age ≥18 years (or country's legal age of majority if the legal age is > 18 years).

Exclusion criteria:

E 01. Previous treatment with mitoxantrone or cabazitaxel. E 02. Prior isotope therapy or
radiotherapy to ≥30% of bone marrow. In case of prior isotope therapy 12 weeks must have
elapsed prior to first study drug administration.

E 03. Adverse events (excluding alopecia and those listed in the specific exclusion
criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common
Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization.

E 04. Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks
prior to enrollment in the study.

E 05. Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial
(pTis, pTa, and pT1) bladder cancer are allowed, as well as any other cancer for which
chemotherapy has been completed ≥ 5 years ago and from which the patient has been
disease-free for ≥ 5 years.

E 06. Participation in another clinical trial and any concurrent treatment with any
investigational drug within 30 days prior to randomization.

E 07. Known brain or leptomeningeal involvement. E 08. Other concurrent serious illness or
medical conditions E 09. 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.

E 10. Any severe acute or chronic medical condition which could impair the ability of the
patient to participate to the study or to comply with the study procedures or interfere
with interpretation of study results.

E 11. Absence of signed and dated Institutional Review Board (IRB)-approved patient
informed consent form prior to enrollment into the study.

E 12. Patients with reproductive potential who do not agree to use accepted and effective
method of contraception during the study treatment period. The definition of "effective
method of contraception" will be based on the Investigator's judgment. Patients' Partners
of childbearing potential (unless surgically sterile, post menopausal or for another
reason have no chance of becoming pregnant) not protected by highly effective
contraceptive method of birth control as defined for contraception in the Informed Consent
Form and /or in a local protocol addendum.

E 13. History of hypersensitivity to docetaxel, or polysorbate 80. E 14. Inadequate organ
and bone marrow function. E 15. Contraindications to the use of corticosteroid treatment.
E 16. Symptomatic peripheral neuropathy grade > 2 (National Cancer Institute Common
Terminology Criteria [NCI CTCAE] v.4.03).

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