Patients who had not responded to DOC in a previous randomised phase II trial received a one-hour intravenous infusion of DOC 70 mg/m2 on day 2 in combination with oral E 840 mg/day divided into three daily administrations on days 1–5. The primary endpoint was a >50 % decrease in PSA; the secondary endpoints were biochemical progression-free survival, overall survival, the objective response rate, and toxicity.
A biochemical response was observed in 52 % of the 25 patients evaluable for response. The only grade 4 event was a cerebral stroke that occurred a few days after the administration of the first treatment course. Treatment discontinuation due to worsened compliance was observed in the patients who received a higher cumulative number of courses.
Our findings suggest that the addition of E may be useful in selected HRPC patients resistant to DOC alone.