Dr Shore on Key Clinical Trial Data in Biochemically Recurrent Prostate Cancer

Neal Shore, MD, FACS, US Chief Medical Officer of Surgery and Oncology, GenesisCare USA, and director, CPI, Carolina Urologic Research Center, of Atlantic Urology, discusses findings from clinical trials in patients with prostate cancer who experience biochemical recurrence.

Many of the studies assessing the utility of PSMA PET are still new and the data from these trials are developing, Shore begins. However, there have been major advances in terms of therapies for patients who experience prostate specific antigen (PSA) relapse following interventional therapy, Shore continues.

One such breakthrough came via findings from the phase 3 EMBARK trial (NCT02319837), which compared enzalutamide (Xtandi) with androgen depravation therapy (ADT) in patients with prostate cancer who had high-risk biochemical recurrence. At a median follow-up of 60.7 months, patients who received enzalutamide plus ADT (n = 355) achieved a 5-year metastasis-free survival (MFS) rate of 87.3% (95% CI, 83.0%-90.6%) compared with 71.4% (95% CI, 65.7%-76.3%) among those treated with ADT alone (n =358; HR, 0.42; 95% CI, 0.30-0.61; P < .001); those who received enzalutamide monotherapy (n = 355) also experienced an MFS benefit vs ADT monotherapy (HR, 0.63; 95% CI, 0.46-0.87; P = .005), with a 5-year MFS rate of 80.0% (95% CI, 75.0%-84.1%). Additionally, no new safety signals were reported with enzalutamide monotherapy or the combination regimen and there were no significant differences in patient quality of life measures.

Data from EMBARK supported the FDA approval of enzalutamide for the treatment of patients with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis in November 2023.

Patients with high-risk biochemical recurrence can now discuss options including enzalutamide plus luteinizing hormone-releasing hormone (LHRH) therapy or enzalutamide monotherapy, Shore explains. The bottom line is that LHRH monotherapy is no longer a standard of care for patients with biochemically recurrent prostate cancer, Shore concludes.