The Phase III E3805 study, funded by the National Institutes of Health, showed that standard androgen ablation therapy (e.g., testosterone suppression) plus docetaxel prolonged survival for patients with newly diagnosed metastatic hormone-sensitive prostate cancer by more than one year. A. Hudis, MD, PhD, former president of ASCO, commented that an older drug had achieved “unprecedented” and “revolutionary” treatment results. According to principal investigator J. Sweeney, MD, a medical oncologist at the Genitourinary Oncology Center at the Dana-Farber Cancer Institute in Boston, we asked the question of whether aggressive therapy should be given at the outset of treatment for hormone-sensitive prostate cancer, or whether we should wait to add docetaxel. This is the first study to identify strategies that may prolong survival in patients with newly diagnosed metastatic prostate cancer. The results suggest that the benefits of the early docetaxel addition regimen described above are significant and could be the standard of care for patients with extensive metastatic disease and tolerant of chemotherapy. Two old treatment regimens were used in the study. Androgen deprivation therapy has been used to treat prostate cancer for more than 50 years. Since docetaxel was approved 10 years ago for patients who progressed after androgen deprivation therapy (e.g., patients with depot-resistant prostate cancer), it has changed the treatment landscape in this area. The aim of this study was to assess whether docetaxel in patients with hormone-sensitive cancers would bring about an improvement in outcomes if given early in the disease process. From 2006 to 2012, the E3805 study included 790 patients with newly diagnosed metastatic prostate cancer who were randomized to receive single androgen deprivation therapy vs. androgen deprivation therapy plus six courses of docetaxel. a prespecified interim analysis conducted in October 2013 showed that docetaxel add-on therapy improved survival. At the ASCO annual meeting, Dr. Sweeney presented updated data on overall survival outcomes. Median overall survival was significantly better in the androgen deprivation plus docetaxel group compared to single androgen deprivation therapy, at 57.6 months and 44 months in the two groups, respectively. The risk of death was reduced by 39% in the combined treatment group, as assessed at different time points. A total of 136 patients died in the monoandrogen deprivation group compared to 101 patients in the androgen deprivation / docetaxel group. A deeper analysis of these data showed that most of the survival benefit was seen in patients with extensive disease – greater bone metastatic load or the presence of liver or lung metastases. In this group (60% of study subjects), the median overall survival time was 32.2 months for the single androgen deprivation group and 49.2 months for the androgen deprivation plus docetaxel group, suggesting a 40% reduction in the risk of death. Longer follow-up is needed to determine the efficacy of docetaxel plus androgen deprivation for patients with low-load metastatic prostate cancer, according to Dr. Sweeney. Docetaxel may delay disease progression depending on the presence of prostate-specific antigen (PSA) or new metastases or worsening symptoms. At year 1, the proportion of patients with PSA levels less than 2 ng/mL was 11.7% in the single androgen deprivation group and 22.7% in the androgen deprivation plus docetaxel group, with a median time to clinical progression of 19.8 months and 32.7 months, respectively. Docetaxel also significantly improved the median time to progression in destructive-resistant prostate cancer, which was 20.7 months and 14.7 months in the two groups (single androgen deprivation therapy group), respectively. Safety According to Dr. D., administration of docetaxel is feasible for the above patient population. The bone marrow toxicity and hematologic toxicity events were consistent with docetaxel. Overall, 28% of patients experienced grade 3 or 4 treatment-related events. Adverse effects associated with docetaxel were mainly neutropenia with fever (6%); sensory neuropathy (1%) and motor neuropathy (1%); and one treatment-related death in 397 patients receiving early docetaxel. Data on quality of life will also be analyzed by the investigators and published at a later date.