Abstract
OBJECTIVE: To report the results of a randomized phase II trial of docetaxel with and without estramustine phosphate (EP) in patients with hormone-refractory prostate cancer (HRPC). PATIENTS AND METHODS: Patients with progressive HRPC were randomized to receive docetaxel 70 mg/m2 on day 1 (arm A), or docetaxel 70 mg/m2 on day 2 plus oral EP three times daily, at a total daily dose of 840 mg, on days 1-5 (arm B). The primary objective of the trial was to evaluate the activity of the treatments in terms of the response in prostate-specific antigen (PSA) level. RESULTS: Forty-five of the 49 patients centrally randomized to arm A and 44 of the 46 in arm B were evaluable for activity. The PSA level decreased by ≥50% in 40% of the patients in arm A and in 75% of those in arm B. The median time to PSA progression was 20 weeks in arm A and 30 weeks in arm B. The patients in arm B had an improvement in pain over time. CONCLUSION: These data support the existence of a possible advantage in combining docetaxel and EP, which should be verified in a specific randomized phase III study.
Original language | English |
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Pages (from-to) | 1080-1085 |
Number of pages | 6 |
Journal | BJU International |
Volume | 102 |
Issue number | 9 |
DOIs | |
Publication status | Published - Nov 2008 |
Keywords
- Docetaxel
- Estramustine phosphate
- Prostate cancer
- Randomized trial
ASJC Scopus subject areas
- Urology