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

Study Overview
=================
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

Official Title
-----------------
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.

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Drug: CABAZITAXEL (XRP6258)
* Drug: DOCETAXEL (XRP6976)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Docetaxel<br>75 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks | Drug: DOCETAXEL (XRP6976)<br>* Pharmaceutical form: solution Route of administration: intravenous<br>|
| Experimental: Cabazitaxel<br>25 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks | Drug: CABAZITAXEL (XRP6258)<br>* Pharmaceutical form: solution Route of administration: intravenous<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median time to PSA progression |  | up to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |