Primary objectives: * To determine the response rate, measurable and non measurable, to Taxotere® in the second line setting. Secondary objectives: * To evaluate the overall safety and toxicity of Taxotere®/prednisone combination as second line therapy in HRPC * To evaluate PSA response (PSA: Prostate Specific Antigen) * To evaluate symptomatic response * To evaluate Quality of life * To evaluate patient safety of weekly versus q3 weekly regimens of Taxotere®.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Pain (pain progression evaluated with the Present Pain Intensity scale form McGill-Melzack questionnaire)
Time frame: During the Study Conduct
Analgesics (assessed by Pain Medication Log)
Time frame: During the study conduct
PSA (PSA response and PSA progression
Time frame: During the study conduct
Tumor lesion assessment,
Time frame: During the study conduct
Overall survival
Time frame: During the study conduct
Progression-free survival
Time frame: During the study conduct
Treatment emergent adverse events recorded by the investigator where intensity was according to NCI-CTC criteria: Standard hematology, blood chemistry and clinical exams.
Time frame: from the inform consent signed up to the end of the study
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