Leonard Gomella, MD, professor, chair, Department of Urology, director, Sidney Kimmel Cancer Center Network, Thomas Jefferson University Hospital, discusses enzalutamide (Xtandi) for patients with nonmetastatic castration-resistant prostate cancer.
There are some agents that are not yet FDA approved but are interesting, says Gomella. For example, there is data with the antiandrogen enzalutamide from the PROSPER trial that may offer a similar benefit as apalutamide (Erleada).
PROSPER is a multinational, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of enzalutamide. The study was initiated in December 2013 at 287 locations and is scheduled to end in May 2020. Patients in the experimental arm are assigned to 160 mg of oral enzalutamide daily. The primary endpoint is metastasis-free survival and secondary endpoints include overall survival, time to prostate-specific antigen (PSA) progression, and time to chemotherapy-free survival.
This trial included similar groups of men with rising PSAs and castrate levels of testosterone, but no evidence of metastatic disease. According to Gomella, at some point in the future, enzalutamide might also be able to achieve an approval. Although it is not yet available in this setting, it is available for more advanced cases of prostate cancer.