Dr. Heath on Recent Approvals in Nonmetastic Prostate Cancer
Elisabeth I. Heath, MD, FACP
Elisabeth I. Heath, MD, FACP, associate center director of Translational Sciences, lead of the Genitourinary Oncology Multidisciplinary Team, medical director of the Infusion Center, and director of Prostate Cancer Research at Barbara Ann Karmanos Cancer Institute, and professor of oncology at Wayne State University School of Medicine, discusses apalutamide (Erleada), enzalutamide (Xtandi), and darolutamide (Nubeqa), which have all been approved for use in nonmetastatic castration-resistant prostate cancer (CRPC).
The National Comprehensive Cancer Network has recognized 3 medications for use in nonmetastatic CRPC: apalutamide, enzalutamide, and darolutamide, explains Heath. These agents are approved based on 3 similarly designed phase III studies. Apalutamide was explored in the SPARTAN study, enzalutamide in the PROSPER study, and darolutamide in the ARAMIS study.
The SPARTAN, PROSPER, and ARAMIS studies enrolled at least 1400 to 1500 patients who received the antiandrogens or placebo plus androgen deprivation therapy (ADT) in a 2:1 randomized fashion, according to Heath. The patients enrolled on these trials were men who received standard imaging with a bone or CT scan, no evidence of cancer, and rising prostate-specific antigen, but at a doubling time of less than 10 months—making this patient population a more aggressive group, says Heath.
The trials’ primary objectives were metastasis-free survival and various secondary endpoints, including overall survival. The results from these trials demonstrated that men benefit from apalutamide, enzalutamide, or darolutamide when added to ADT over placebo/ADT, concludes Heath.