Early Switch From First-Line Docetaxel/Prednisone to Cabazitaxel/Prednisone and the Opposite Sequence, Exploring Molecular Markers in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

- Participants were treated until progressive disease, unacceptable toxicity, death, or
participant's refusal of further study treatment. All participants were followed until
death or the study cut-off date, whichever came first.

- Study cut-off was 1 month after the last participant last treatment.

- Participants alive at the cut-off date were not followed for overall survival.

Inclusion criteria :

- Histologically- or cytologically-confirmed prostate adenocarcinoma with documented
distant metastases (M1 disease).

- Progressive disease while receiving hormonal therapy or after surgical castration.

- Effective castration (serum testosterone levels ≤50 ng/dL) by orchiectomy and/or
luteinizing hormone releasing hormone agonists or antagonist with or without
anti-androgens.

Exclusion criteria:

- Prior chemotherapy for prostate cancer, except estramustine and adjuvant/neoadjuvant
treatment completed >3 years ago. Prior treatment with sipuleucel-T immunotherapy was
allowed at the condition participant did not receive prior chemotherapy.

- Less than 28 days elapsed from prior treatment with estramustine, radiotherapy or
surgery to the time of random allocation.

- Prior beta isotope therapy, whole pelvic radiotherapy, or radiotherapy to >30% of bone
marrow.

- 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 for Adverse Events [NCI CTCAE] v4.03) at the time of
random allocation.

- Less than 18 years of age.

- Eastern Cooperative Oncology Group (ECOG) performance status >2.

- History of brain metastases, uncontrolled spinal cord compression, or carcinomatous
meningitis or new evidence of brain or leptomeningeal disease.

- Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial
(pTis, pTa and pT1) bladder cancer were allowed, as well as any other cancer for which
chemotherapy had been completed ≥3 years ago and from which the participant had been
disease-free for ≥3 years.

- Participation in another clinical trial and any concurrent treatment with any
investigational drug within 30 days prior to random allocation.

- Any of the following within 6 months prior to study enrollment: myocardial infarction,
severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York
Heart Association (NYHA) class III or IV congestive heart failure, stroke or transient
ischemic attack.

- Any of the following within 3 months prior to random allocation: treatment resistant
peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory
bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled
thromboembolic event.

- Acquired immunodeficiency syndrome (AIDS)-related illnesses or known HIV disease
requiring antiretroviral treatment.

- Any severe acute or chronic medical condition which could impair the ability of the
participant to participate in to the study or interfere with interpretation of study
results, or participant unable to comply with the study procedures.

- Concomitant treatment with biphosphonates or denosumab except if the dose had been
stable for 4 weeks prior to enrollment.

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

- Participants with reproductive potential who did not agree to use an accepted and
effective method of contraception during the study treatment period. The definition of
"effective method of contraception" was based on the investigator's judgment.

- History of hypersensitivity to docetaxel or polysorbate 80.

- Inadequate organ and bone marrow function.

- Contraindications to the use of corticosteroid treatment.

- Symptomatic peripheral neuropathy grade >2 (NCI CTCAE v.4.03).

- Treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a
two-week wash-out period was necessary for participants who were already on these
treatments).

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