Effect of adding docetaxel to androgen-deprivation therapy in patients with high-risk prostate cancer with rising prostate-specific antigen levels after primary local therapy: A randomized clinical trial
JAMA May 15, 2019
Oudard S, et al. - Researchers evaluated the benefit of androgen-deprivation therapy (ADT) plus docetaxel after primary local therapy and high-risk factors in patients with rising levels of prostate-specific antigen (PSA), but no evidence of metastatic disease. For this open-label, phase 3, randomized superiority trial, study participants were randomly assigned to receive ADT (1 year) plus docetaxel, 70 mg/m2 (every 3 weeks [6 cycles]), or ADT alone (1 year). In total, 254 patients were randomized (1:1) to the ADT plus docetaxel arm (median age, 64 years) and the ADT alone arm (median age, 66 years). Compared to ADT alone, in patients with high-risk prostate cancer and rising PSA levels and no evidence of metastatic disease, combined ADT plus docetaxel therapy with curative intent did not significantly improve PSA progression-free survival. Neutropenia, febrile neutropenia, and thrombocytopenia were the most common grade 3 or 4 hematologic toxic effects in the ADT plus docetaxel arm.
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