ENACT randomized phase 2 clinical trial with patients with low risk or intermediate risk prostate cancer received enzalutamide 160 mg for one year compared to active surveillance.
Patients in the enzalutamide group had a 46% lower hazard ratio of progression and patient undergoing active surveillance alone and the decrease was significant.
The median time to pathological or therapeutic progression was not reached in either arms.
The incidence of pathological or therapeutic prostate cancer progression at one year was lower with enzalutamide! however, no differences were observed at two years.
In patients with Gleason score of seven the median time to progression to prostate cancer was not reached in the enzalutamide group, compared with 30 months in the active surveillance group.
In a metaanalysis of more than 6700 men showed 99.8 cancer specific survival at 6.7 years of follow up, with 0.4% rate of systemic progression.