The independent Data and Safety Monitoring Committee overseeing the trial recommended to the National Cancer Institute (NCI), part of NIH, that the study results be made public because a recent planned interim analysis showed the prolongation in overall survival. Full details from this early analysis will be presented at a scientific meeting in 2014 and in a peer-reviewed publication.

The study enrolled 790 me

Men received either ADT alone or ADT with the chemotherapy drug docetaxel every three weeks over a period of 18 weeks. In addition to examining whether the study participants lived longer with the addition of chemotherapy, investigators looked at whether the extent of a patient’s metastatic disease was high or low at the start of treatment. Approximately two thirds of patients had a high extent of disease which, according to the study, meant the disease had spread to major organs such as the liver, had a spread resulting in four or more bone lesions, or both.

A significant improvement in the overall survival was noted favoring the participants who had received docetaxel chemotherapy in addition to the ADT compared to the ADT alone (three-year survival rates of 69.0 percent vs. 52.5 percent respectively). Further analysis showed that patients with a high extent of metastatic disease accounted for most of the benefit in the overall survival from docetaxel plus ADT (three-year survival rates of 63.4 percent vs. 43.9 percent for ADT alone). Median follow-up to date is two years.

“The results of this study are practice-changing,” said lead investigator Christopher Sweeney, Dana Farber Cancer Institute, Boston. “We have strong scientific evidence that patients with the most advanced metastatic prostate cancer benefit from the early addition of docetaxel to ADT and not waiting until the cancer has progressed on hormonal therapy. The findings of this study are important both for improving the clinical care we deliver now and in designing new clinical trials as we strive to further improve the lives of men with metastatic prostate cancer.”

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