Fred Saad, MD, FRCS, discusses the randomized phase 3 SPARTAN trial in nonmetastatic castration-resistant prostate cancer.
Fred Saad, MD, FRCS, professor and chief of Urology, director of Genitourinary Oncology, Raymond Garneau Chair in Prostate Cancer, University of Montreal Hospital Center, and director, Prostate Cancer Research, Montreal Cancer Institute, discusses the randomized phase 3 SPARTAN trial in nonmetastatic castration-resistant prostate cancer (M0CRPC).
The SPARTAN trial randomized men with M0CRPC 2:1 to apalutamide (Erleada) or placebo, says Saad. These patients were considered to be at high risk of developing metastatic disease based on a prostate-specific antigen doubling time of less than 10 months.
The study’s primary end point was metastasis-free survival, although the risk of second progression or death (PFS2) was also evaluated to determine whether starting subsequent therapy up front or when patients developed metastases was superior, explains Saad.
The final survival results of the SPARTAN trial that were presented at the 2020 ASCO Virtual Scientific Program showed that the patients who received apalutamide plus androgen-deprivation therapy (ADT) had a significant overall survival improvement compared with those who received placebo plus ADT.
Additionally, apalutamide prolonged median PFS2 by 14.4 months compared with placebo, concludes Saad.