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.
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
- 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.