Study of Cabazitaxel Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer (PROSPECTA)

• Proportion of patients with episode of neutropenia grade ≥3 [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: Yes ]
• Rate of febrile neutropenia [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: Yes ]
• Rate of diarrhea grade ≥3 [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: Yes ]
• PSA response rate [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: No ]
• Circulating Tumor Cells Count (CTC) rate [ Time Frame: Day 42, Day 84, Day 126 and End of Treatment ] [ Designated as safety issue: No ]
• Changes from baseline in score derived from the Functional assessment of cancer therapy-prostate (FACT-P) and the Trial Outcome Index (TOI) [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: No ]
• Number of patients with adverse events [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: Yes ]

• Proportion of patients with episode of neutropenia grade ≥3 [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: Yes ]
• Rate of febrile neutropenia grade >=3 [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: Yes ]
• Rate of diarrhea grade ≥3 [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: Yes ]
• PSA response rate [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: No ]
• Circulating Tumor Cells Count (CTC) rate [ Time Frame: Day 42, Day 84, Day 126 ] [ Designated as safety issue: No ]
• Changes from baseline in score derived from the Functional assessment of cancer therapy-prostate (FACT-P) and the Trial Outcome Index (TOI) [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: No ]
• Number of patients with adverse events [ Time Frame: up to 24 months (every 21 days) ] [ Designated as safety issue: Yes ]

Primary Objective:

- To assess effectiveness of prophylactic treatment of hematological complications (grade ≥ 3 neutropenia) resulting from cabazitaxel treatment for 21 days after treatment initiation.

Secondary Objectives:

• PSA response rate;
• Descriptive assessment of CTC (circulating Tumor Cells);
• Rates of grade ≥ 3 neutropenia and febrile neutropenia and grade ≥3 diarrhea over the treatment period;
• Description of the Health Quality of Life of the patients;
• Incidence of adverse events.

Screening: 15 days Treatment: until disease progression Post-treatment Follow-up: 12 months

• Drug: CABAZITAXEL (XRP6258)
  Pharmaceutical form: solution Route of administration: intravenous
• Drug: Prednisone
  Pharmaceutical form: tablet Route of administration: oral
• Drug: Ciprofloxacin
  Pharmaceutical form: tablet Route of administration: oral
• Drug: G-CSF (Granulocyte colony-stimulating factor)
  Pharmaceutical form: solution Route of administration: subcutaneous

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.