Continued Treatment With Docetaxel Versus Switch to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in Patients With Castration-Resistant Metastatic Prostate Cancer

Phase II Randomized Study of Continuing Treatment With Docetaxel Versus Switching to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in the First Line Treatment of Patients With Castration-Resistant Metastatic Prostate Cancer.

Primary Objective:

• To compare the continuation of treatment with docetaxel versus switching to cabazitaxel regarding the time to PSA (Prostatic Specific Antigen) progression (TTP-PSA), in patients with Castration-Resistant Prostate Cancer (CRPC) that, after four cycles of docetaxel, have minor PSA response (defined as a reduction between 1% and 49%) or increase of up to 24% in PSA levels.

Secondary Objectives:

• PSA response rate
• Overall survival (OS)
• Incidence of Adverse Events

Screening: 21days (+7 days) Treatment: until PSA progression Post-treatment Follow-up: 2 years

Inclusion criteria :

• Documentation of histological prostate cancer;
• Patients with metastatic CRPC (Castration-Resistant Metastatic Prostate Cancer) who progressed with hormone deprivation, including the withdrawal of antiandrogen-class drugs for at least 4 weeks, and 6 weeks for bicalutamide or if documented that PSA did not decrease during 3 months of this therapy;
• Documentation of metastasis by imaging (computerized tomography [CT], magnetic resonance imaging [MRI] or bone scan), in patients with PSA < 20 ng/mL at the time of inclusion
• Provide minor PSA response (characterized by a reduction between 1% and 49%) or increase up to 24% in PSA levels, in relation to the value measured before starting docetaxel therapy, measured at least 7 days after the fourth cycle of docetaxel;
• Patient has received 4 cycles of docetaxel at a dose of 75 mg/m2 ;
• ECOG performance status of 0 or 1;
• Marrow, liver and renal function within acceptable values;
• PSA ≥ 2 ng/mL;
• Testosterone level ≤ 50 ng/dL (for patients with no prior history of orchiectomy).

Exclusion criteria:

• Prior use of chemotherapy, except for docetaxel for four cycles;
• Documented disease progression during treatment with docetaxel (first 4 cycles);
• Patients with metastases resulting in neurological damage;
• Inability to continue receiving gonadotropin-releasing hormone agonists in patients with no prior history of orchiectomy;
• Use of recombinant methionyl human granulocyte-colony stimulating factor non-glycosylated (G-CSF) in the 24 hours preceding baseline;
• Any other current neoplasia or over the past 5 years, except for basal cell skin carcinoma or squamous skin cell carcinoma;
• Known seropositivity for HIV (Human immunodeficiency Virus );
• Concomitant diseases, such as significant neurological or psychiatric disease; uncontrolled hypercalcemia or any other serious comorbidity;
• Hypersensitivity or allergy to any of the study treatments.

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