Plain Language SummaryWhat is this summary about?The EMBARK study looked at enzalutamide treatment for people assigned male at birth who had hormone-sensitive prostate cancer. Using standard medical scans (CT scans and bone scans) at the beginning of the study, there was no evidence that people’s cancer had spread to other parts of the body. However, their prostate-specific antigen (PSA) levels were rising quickly – this is known as high risk biochemical recurrence. Researchers compared 3 treatments: enzalutamide + androgen deprivation therapy (known as ADT), enzalutamide only (without ADT), and placebo + ADT. Previous results showed that people who took enzalutamide + ADT or enzalutamide only lived longer without their cancer spreading compared with people who took placebo + ADT.In this part of the study, researchers wanted to find out how long it took for sexual interest, activity, satisfaction, and erectile function to decrease with each treatment. Researchers also wanted to find out how taking a break from treatment affected people’s quality of life.What were the results?It took longer for sexual activity to decrease for people who took enzalutamide only compared with people who took placebo + ADT. People who took enzalutamide + ADT had a similar amount of time before their sexual activity decreased compared with people who took placebo + ADT. People who took enzalutamide only, enzalutamide + ADT, or placebo + ADT maintained their quality of life during treatment and after stopping treatment. Taking a break from treatment improved symptoms from hormone changes that can be caused by the treatments, such as enlarged breasts or hot flashes.What do the results mean?For people with hormone-sensitive prostate cancer and high-risk biochemical recurrence, treatment with enzalutamide only may allow people to stay sexually active for longer than treatment with ADT only. Adding enzalutamide to ADT does not decrease sexual activity more quickly than treatment with ADT only. Enzalutamide may help people live longer without their cancer spreading and without decreasing their quality of life. This means that enzalutamide with or without ADT may be a suitable treatment option for people with hormone-sensitive prostate cancer and high-risk biochemical recurrence.
Freedland et al. (Sun,) studied this question.