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Opinion|Videos|November 22, 2024

Innovative Treatment Strategies in High-Risk Biochemical Recurrence: Insights From the EMBARK Trial

Key Takeaways

  • Enzalutamide plus GnRH significantly improved metastasis-free survival in nmCSPC patients with high BCR risk compared to monotherapies.
  • The study population included patients with PSA doubling time ≤ 9 months, previously treated with radical prostatectomy or radiotherapy.
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Panelists discuss how recent data from the EMBARK study indicates that in patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) at high risk for biochemical recurrence (BCR), enzalutamide combined with gonadotropin-releasing hormone (GnRH) significantly improves metastasis-free survival compared with monotherapy options, with no new safety signals reported.

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Video content above is prompted by the following:

  1. What recent data has been shown in patients with nmCSPC and high risk of BCR?
    1. BCR: prostate-specific antigen [PSA] doubling time ≤ 9 months
    2. EMBARK study: enzalutamide +GnRH) vs GnRH monotherapy vs enzalutamide monotherapy (Freedland et al, NEJM, 2023)
      1. Patient population: nmCSPC initially treated by radical prostectomy or radiotherapy, or both, with PSA doubling time ≤ 9 months
      2. Follow-up, 60.7 months
      3. Metastasis-free survival was:
        1. 87% for enzalutamide + GnRH (HR for risk of progression or death [compared to GnRH], 0.42; 95% CI, 0.30-0.61; P < .001)
        2. 80% for enzalutamide (HR for risk of progression or death [compared to leuprolide], 0.63; 95% CI, 0.46-0.87; P = .005)
        3. 71% for leuprolide
      4. No new safety signals

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