Prostatic Neoplasms
Conditions
Brief summary
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
Detailed description
Screening: 21days (+7 days) Treatment: until PSA progression Post-treatment Follow-up: 2 years
Interventions
Pharmaceutical form: solution Route of administration: intravenous
Pharmaceutical form: solution Route of administration: intravenous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median time to PSA progression | up to 60 days |
Secondary
| Measure | Time frame |
|---|---|
| PSA response rate: Percentage of patients with a decrease of at least 50% in the PSA | up to 60 days |
| Overall Survival: Median time elapsed between the date of starting treatment until death by any cause | up to a maximum of 2 years |
| Number of patients with adverse events | up to a maximum of 2 years |
Countries
Brazil
Outcome results
None listed