Weekly docetaxel and prednisolone versus prednisolone alone in androgen-independent prostate cancer: a randomized phase II study.

Background: Due to its palliative effect and prostate-specific antigen (PSA) decrease, many clinicians have considered prednisolone monotherapy to be the standard systemic treatment in patients with androgen-independent prostate cancer (AIPC). This approach should be compared with docetaxel (Taxotere)+prednisolone.

Methods: A total of 109 eligible patients were entered into a randomized phase II study (arm A: Taxotere+prednisolone [30 mg m(-2) weekly during 5 of 6 wk+prednisolone 5 mg x 2 per os daily]; arm B: prednisolone [5 mg x 2 per os daily]). Biochemical response (confirmed > or = 50% PSA reduction of the baseline level at 6 wk) was the primary endpoint with subjective progression, quality of life, and progression-free and overall survival as secondary outcomes.

Results: Biochemical response at 6 wk was recorded in 29 of 54 evaluable patients in arm A (54%; 95% CI: 40-67%) and 13 of 50 patients in arm B (26%; 95% CI: 14-38%), with similar response rates at 12 wk and if based on all eligible patients. Median progression-free survival was 11 mo (95% CI: 5.8-16.2 mo) in arm A and 4 mo in arm B (95% CI: 2.4-5.6 mo). Median overall survival was 27 mo in arm A (95% CI: 19.8-34.1 mo) and 18 mo in arm B (95% CI: 15.2-20.8 mo). Pain relief and quality-of-life assessment indicated superiority of the arm A treatment, without unacceptable toxicity.

Conclusion: Docetaxel+prednisolone should become the first-line systemic standard treatment for AIPC as a more effective treatment than prednisolone monotherapy. Weekly applications of docetaxel are well tolerated.