A randomized phase II trial comparing weekly taxotere plus prednisolone versus prednisolone alone in androgen-independent prostate cancer

Prednisolone monotherapy has been the standard systemic treatment in many patients with androgen- independent prostate cancer and should today be compared to treatment with Taxotere plus prednisolone. One hundred and thirty four patients were entered into a randomized phase II study [arm A: Taxotere plus prednisolone (30 mg/m2 weekly during 5 of 6 weeks + prednisolone 5 mg orally twice daily); arm B: prednisolone (5 mg orally twice daily)]. Biochemical response at 6 weeks was the primary outcome parameter, with progression-free and overall survival as secondary outcomes. Biochemical response at 6 weeks was recorded in 29 of 54 evaluable patients in arm A [54%; 95% confidence interval (CI) 40-67%] and 13 of 50 patients in arm B (26%; 95% CI 14-38%), with a similar difference in response rates at 12 weeks. Median progression-free survival was 11 months in arm A (95% CI 5.8-16.2)and 4 months in arm B (95% CI 2.4-5.6). Median overall survival was 27 months in arm A (95% CI 19.8-34.1) and 18 months in arm B (95% CI 15.2-20.8). Assessment of pain and quality of life showed superiority of arm A treatment, without unacceptable toxicity. Taxotere plus prednisolone is recommended as systemic standard treatment in androgen-independent prostate cancer.