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

Age

18–any

Sex

MALE

Healthy volunteers

Not accepted

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).

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.