Key Trials in Prostate Cancer Research

Lisa Holle, PharmD, BCOP, FHOPA, associate clinical professor at the University of Connecticut, discusses recent key trials involving non-metastatic castrate-resistant prostate cancer.

Lisa Holle, PharmD, BCOP, FHOPA: Over the last year and a half or so, there have been 2 drugs that have been evaluated in the treatment of non-metastatic castration-resistant prostate cancer. There’s actually a third one that data was just presented recently. The drugs are apalutamide and enzalutamide, that I talked about during the discussion, and the third drug is darolutamide, that the information was published on the phase 3 trial in the New England Journal of Medicine.

So both trials looking at evaluating apalutamide and enzalutamide were phase 3 randomized controlled trials comparing against placebo because that was really standard of care was given androgen deprivation therapy alone in those patients. And they were looking to determine whether or not the addition of apalutamide to androgen deprivation therapy or enzalutamide would prolong the time to the development of metastases, so the metastasis-free survival time. And both of those trials showed a statistically significant improvement of about 2 years in terms of adding on this additional anti-androgen therapy and with overall tolerability, and I think that will change how we treat this population of prostate cancer patients. And the implications for pharmacists are that we now need to learn about a new anti-androgen. Apalutamide was not on the marker prior to the results of this study, and how we might use enzalutamide in this different population. So there’s learning the drug interactions, how to counsel patients on the drugs, what side effects to monitor for are really going to be key areas for pharmacists to become involved in.