To compare the efficacy of both strategies (reference treatment: Docetaxel+Prednisone and experimental treatment: Docetaxel+Estramustine+Hydrocortisone) by means of PSA values. To determine the time to treatment failure in both strategies To determine the overall and specific cause survival To evaluate the safety profile To analyze the Quality of Life
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Docetaxel iv 80 mg + Oral estramustine-pills 140 mg + Oral hydrocortisone-pills 20 mg. Combination of these 3 drugs every 3 weeks
Docetaxel iv 80 mg + oral prednisone-pills 5 mg. Combination of these 2 drugs every 3 weeks.
Sanofi-Aventis Administrative Office
Barcelona, Spain
Response rate over 50% in PSA
Time frame: every 3 weeks up to end of treatment and every month until PSA progression
Time to treatment failure
Time frame: from Informed Consent signature up to end of the study
Time to progression
Time frame: from Informed Consent signature up to study end
Overall and specific cause surveillance
Time frame: from Informed Consent signature up to study end
Toxicity profile
Time frame: from Informed Consent signature up to study end
Patients' Quality of Life
Time frame: Before first cycle, every 2 cycles throughout the treatment period, at the study end and first follow-up visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.