Prostatic Neoplasms
Conditions
Brief summary
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
Interventions
DRUGDocetaxel + Estramustine + Hydrocortisone
Docetaxel iv 80 mg + Oral estramustine-pills 140 mg + Oral hydrocortisone-pills 20 mg. Combination of these 3 drugs every 3 weeks
DRUGDocetaxel + Prednisone
Docetaxel iv 80 mg + oral prednisone-pills 5 mg. Combination of these 2 drugs every 3 weeks.
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histological or cytological confirmation of prostate adenocarcinoma * Advanced prostate carcinoma. * Previous treatment with hormones * Levels of testosterone \< 50 ng/dL * Good hematological, liver and kidney function * Previous treatment with surgery or radiotherapy, at least 4 weeks since end of treatment is allowed (the patient should have been recovered from any side effects.
Exclusion criteria
* Previous chemotherapy (estramustine included). * Second line hormonotherapy (oestrogens, gestagens, ketoconazole, ...included) * Previous treatment with radiotherapy (isotopes) or previous radiotherapy over \> 25% of the marrow * Any malignant process with a free disease interval under 5 years, exception done to non-melanoma skin cancer. * Concomitant serious diseases * Concomitant treatment with any other neoplassic therapy (exception done to LHRH agonists and/or biphosphonates). * Contraindication for the treatment with estramustine. * Previous history of pulmonary embolism, thromboembolic disease, previous treatment with anticoagulants (except aspirin), active thrombophlebitis or hypercoagulation. * Previous history of pulmonary spillage or ascitis. 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 |
|---|---|
| Response rate over 50% in PSA | every 3 weeks up to end of treatment and every month until PSA progression |
Secondary
| Measure | Time frame |
|---|---|
| Time to treatment failure | from Informed Consent signature up to end of the study |
| Time to progression | from Informed Consent signature up to study end |
| Overall and specific cause surveillance | from Informed Consent signature up to study end |
| Toxicity profile | from Informed Consent signature up to study end |
| Patients' Quality of Life | Before first cycle, every 2 cycles throughout the treatment period, at the study end and first follow-up visit |
Countries
Spain
Outcome results
None listed