Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer Who Have Relapse in Biochemistry Whilst Androgenic Blockage
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.