Therapy, Prostatic Neoplasms
Conditions
Keywords
docetaxel, prednisolone, drug combination
Brief summary
The purpose of this study is to evaluate the safety of docetaxel administered every 3 weeks repeatedly for 11 and more cycles and in combination with daily prednisolone for metastatic hormone refractory prostate cancer.
Interventions
combined treatment with prednisolone
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
Patients who completed the 10 cycles of docetaxel administrations in the preceding XRP6976J/2101 study and wish to continue docetaxel administrations,and who have no alternative therapy for hormone refractory prostate cancer according to the Investigator's judgment.
Exclusion criteria
* Continuation in the study would be detrimental to the patient's well-being * Development of life-threatening and/or toxic conditions not manageable by symptomatic care, dose reduction, or delay of dosing * Obvious disease progression (rising prostate specific antigen, any increase of ≥ 20 % in the sum of the measurable lesion in comparison to the nadir value, and progression in non-measurable lesion) * Patients treated with anti-cancer treatment other than study therapy after completion of 10 cycles of study treatment in the XRP6976J/2101 study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of adverse events on each grade evaluated by National Cancer Institute Common Toxicity Criteria (Version 2.0) | First treatment up to 37 months |
Secondary
| Measure | Time frame |
|---|---|
| No obvious disease progression | First treatment up to 37 months |
Countries
Japan
Outcome results
None listed