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

Study Overview
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Brief Summary
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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.

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

Official Title
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A Phase IV, Multicenter, National, Non-comparative, Open-label Study of Cabazitaxel, Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Second-line Treatment of Patients With Metastatic Castration-resistant Prostate Cancer and After Failure of Docetaxel-based Chemotherapy. Descriptive Assessment of the Circulating Tumor Cells in This Context.

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: CABAZITAXEL (XRP6258)
* Drug: Prednisone
* Drug: Ciprofloxacin
* Drug: G-CSF (Granulocyte colony-stimulating factor)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cabazitaxel<br>25 mg/m2, administered as a 1-hour intravenous infusion, on Day 1 of each cycle, every 21 days Prednisone: 10 mg daily throughout the treatment with cabazitaxel Ciprofloxacin: at a dose of 500 mg for 8 days twice daily (total dose 1.0 g) Granulocyte-Colony Stimulating Factors: maximum dose of 600ug for 7 days or until Absolute Neutrophils Count reaches level ≥ 10.000/mm3 | Drug: CABAZITAXEL (XRP6258)<br>* Pharmaceutical form: solution Route of administration: intravenous<br>Drug: Prednisone<br>* Pharmaceutical form: tablet Route of administration: oral<br>Drug: Ciprofloxacin<br>* Pharmaceutical form: tablet Route of administration: oral<br>Drug: G-CSF (Granulocyte colony-stimulating factor)<br>* Pharmaceutical form: solution Route of administration: subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with some episode of neutropenia classified as grade ≥ 3 |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with episode of neutropenia grade ≥3 |  | up to 24 months (every 21 days) | 
| Rate of febrile neutropenia |  | up to 24 months (every 21 days) | 
| Rate of diarrhea grade ≥3 |  | up to 24 months (every 21 days) | 
| PSA response rate |  | up to 24 months (every 21 days) | 
| Circulating Tumor Cells Count (CTC) rate |  | Day 42, Day 84, Day 126 and End of Treatment | 
| Changes from baseline in score derived from the Functional assessment of cancer therapy-prostate (FACT-P) and the Trial Outcome Index (TOI) |  | up to 24 months (every 21 days) | 
| Number of patients with adverse events |  | up to 24 months (every 21 days) |