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

Author(s):

Joeseph Renzulli, MD,Ganesh V. Raj, MD, PhD

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.
Enzalutamide plus GnRH showed a hazard ratio of 0.42 for progression or death, indicating substantial efficacy.
No new safety signals were observed, supporting the safety profile of the combination therapy.

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.

EP: 1.Emerging Trends and Rising Prevalence of mCSPC

EP: 2.Defining mCSPC: Diagnostic Criteria, Imaging Approaches, and Patient Identification

EP: 3.Overcoming Unmet Needs in Treating mCSPC: ADT Monotherapy vs Multimodal Approaches

EP: 4.Managing Biochemical Recurrence in Prostate Cancer: Risk Stratification and Treatment Decisions

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EP: 5.Innovative Treatment Strategies in High-Risk Biochemical Recurrence: Insights From the EMBARK Trial

EP: 6.Navigating Treatment Options in mCSPC: Choosing the Right Doublet or Triplet Therapy

EP: 7.Managing Cognitive and Sexual Health in Prostate Cancer Patients on Hormonal Therapy

Video content above is prompted by the following:

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