ESMO 2018: Enzalutamide in Men With Nonmetastatic Castration-Resistant Prostate Cancer
Posted: Wednesday, November 14, 2018
Men with nonmetastatic castration-resistant prostate cancer and rapidly rising prostate-specific antigen (PSA) levels experienced a reduction in developing metastases or death with enzalutamide treatment, according to the PROSPER study. In fact, the findings were consistent across subgroups of patients by both age and geographic region. Karim Fizazi, MD, PhD, of the Institut Gustave Roussy in France, presented these results at the 2018 European Society for Medical Oncology (ESMO) Congress (Abstract 805P) in Munich.
The researchers enrolled 1,401 patients in the phase III, randomized, double-blind, placebo-controlled study. Eligible men had nonmetastatic castration-resistant prostate cancer, a rapidly rising PSA doubling time less than or equal to 10 months, and a PSA level greater than or equal to 2 ng/mL at screening. The men were assigned randomly 2:1 to receive enzalutamide or placebo. All of the patients continued androgen-deprivation therapy.
Enzalutamide reduced the risk of metastasis or death by 71%, with the reduction being similar across all subgroups. More patients in the subgroup older than age 75 reported having an adverse event as being the main reason for stopping treatment (13% with enzalutamide vs. 10% with placebo) compared with the overall group (9% with enzalutamide vs. 6% with placebo). In addition, more patients in North America reported falls than in Europe or the rest of the world (15% vs. 7% vs. 10%).
