The Transition From Phase II To Phase III Studies

monotherapy offers similar improvements in survival and PSA response rate as the docetaxel/estramustine combination. One of the key messages of our trial is that estramustine phosphate significantly increases toxicity: more patients in the docetaxel/ estramustine group (45%) had at least one grade 3/4 toxicity compared with those who received docetaxel alone (21%; P .005). Although, we all believe in what we are doing for the patients with CRPC, we should not forget that we are dealing with palliative patients. These patients are old, with frequent comorbidities. The survival benefit provides by docetaxel remains modest. "Primum non nocere" is one of the most important principle of antic and modern medicine, particularly in the case of palliative disease. In this context, we strongly believe that estramustine should not be used in combination with chemotherapy, based on the available data. Only a large randomized trial including several hundreds of patients could, maybe, show a small clinical benefit in favor of estramustine-based chemotherapy. Would it be relevant in regard of the quality of life of our patients?