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Before results of phase III trials leading to FDA approval of docetaxel for castrate-progressive prostate cancer were published (N Engl J Med 2004; 351:1502 and N Engl J Med 2004; 351:1513), various treatments were used to manage the disease. These included conventional androgen-deprivation therapy (ADT) as well as a popular regimen consisting of ketoconazole and doxorubicin alternating weekly with vinblastine and estramustine (KA/VE).
To test whether the addition of KA/VE to ADT would delay progression of castrate-resistant disease, investigators conducted a phase III trial involving 286 patients with nonlocalized, ADT-maintained prostate cancer. Patients with prostate-specific antigen (PSA)-only disease were included if their PSA doubling …