Prostate Cancer
Conditions
Brief summary
Primary Objective: \- To assess effectiveness of prophylactic treatment of hematological complications (grade ≥ 3 neutropenia) resulting from cabazitaxel treatment for 21 days after treatment initiation. Secondary Objectives: * PSA response rate; * Descriptive assessment of CTC (circulating Tumor Cells); * Rates of grade ≥ 3 neutropenia and febrile neutropenia and grade ≥3 diarrhea over the treatment period; * Description of the Health Quality of Life of the patients; * Incidence of adverse events.
Detailed description
Screening: 15 days Treatment: until disease progression Post-treatment Follow-up: 12 months
Interventions
Pharmaceutical form: solution Route of administration: intravenous
DRUGPrednisone
Pharmaceutical form: tablet Route of administration: oral
DRUGCiprofloxacin
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: solution Route of administration: subcutaneous
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * Histologically proven Castration-Resistant Prostate Cancer (stage IV only); * Prior failure of treatment with docetaxel; o Documentation of metastasis by imaging. * Performance status 0 or 1;
Exclusion criteria
* Previous treatment with chemotherapy, except for docetaxel; * Previous use of abiraterone; * Inability to maintain treatment with androgen deprivation if no previous history of orchiectomy; * Presence of any other active malignancy or history of any tumor diagnosed in the last 5 years, except basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the skin, bladder or anal canal (these tumors do not prevent participation if they have been treated, even in the last 5 years); * Hypersensitivity or known allergy to any of the treatments under study, including history of severe hypersensitivity reaction (≥grade 3) to docetaxel and/or to polysorbate 80 containing drugs * History of congestive heart failure or myocardial infarction within the last 6 months, or uncontrolled cardiac arrhythmias, angina pectoris or uncontrolled hypertension; * Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus) * Presence of severe comorbidity, which in the opinion of the investigator, puts the patient at risk or impairs compliance to the protocol; * Known seropositivity for HIV; * Presence of significant psychiatric or neurological disease, in the investigator's opinion; * Presence of uncontrolled hypercalcemia; * Refusal to use appropriate contraception during the study period; * Participation in any clinical trial in the last 12 months, unless there is benefit to the patient to be justified by the principal investigator * Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 * Inadequate organ and bone marrow function 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 |
|---|---|
| Proportion of patients with some episode of neutropenia classified as grade ≥ 3 | 21 days |
Secondary
| Measure | Time frame |
|---|---|
| Rate of febrile neutropenia | up to 24 months (every 21 days) |
| Rate of diarrhea grade ≥3 | up to 24 months (every 21 days) |
| PSA response rate | up to 24 months (every 21 days) |
| Proportion of patients with episode of neutropenia grade ≥3 | up to 24 months (every 21 days) |
| Changes from baseline in score derived from the Functional assessment of cancer therapy-prostate (FACT-P) and the Trial Outcome Index (TOI) | up to 24 months (every 21 days) |
| Number of patients with adverse events | up to 24 months (every 21 days) |
| Circulating Tumor Cells Count (CTC) rate | Day 42, Day 84, Day 126 and End of Treatment |
Countries
Brazil
Outcome results
None listed