Enzalutamide Shows Significant Benefits for High-Risk Biochemically Recurrent Prostate Cancer Patients According to EAU Definition

EMBARK results

Enzalutamide Shows Significant Benefits for High-Risk Biochemically Recurrent Prostate Cancer Patients According to EAU Definition

New Analysis from EMBARK Trial Confirms Treatment's Value for European Criteria

A recent post hoc analysis of the pivotal EMBARK trial has demonstrated that enzalutamide (Xtandi) provides significant benefits for patients with high-risk biochemically recurrent prostate cancer as defined by the European Association of Urology (EAU) criteria. The results, published in March 2025 in Prostate Cancer and Prostatic Diseases, reinforce the value of this treatment option for a broader patient population than originally studied.

Key Findings

The analysis showed that in patients meeting the EAU definition of high-risk biochemical recurrence:

  • Metastasis-free survival (MFS) improved significantly with enzalutamide plus leuprolide combination therapy (hazard ratio 0.37) and with enzalutamide monotherapy (hazard ratio 0.57) compared to leuprolide alone
  • At 5 years, the MFS rate was 88.8% for the combination therapy group versus 72.9% for leuprolide alone
  • For enzalutamide monotherapy, the 5-year MFS rate was 81.3% compared to 72.9% for leuprolide alone
  • The safety profile was consistent with previous studies, with no new safety concerns identified

What This Means for Patients

The EMBARK trial had already led to FDA approval of enzalutamide (with or without androgen deprivation therapy) for treatment of nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis. This new analysis confirms that the benefits extend to patients defined as high-risk according to European guidelines.

"These findings are important because they show that the benefits of enzalutamide are consistent across different definitions of high-risk biochemical recurrence," said Dr. Neal D. Shore, one of the study's authors. "This gives clinicians greater confidence in identifying patients who may benefit from this treatment approach."

About the EAU Definition

The European Association of Urology defines high-risk biochemical recurrence as:

  • PSADT ≤ 12 months or pathological ISUP grade 4-5 (equivalent to Gleason score > 7) after radical prostatectomy
  • Interval to biochemical failure ≤ 18 months or biopsy ISUP grade 4-5 after radiation therapy

Quality of Life Considerations

Additional analyses from the EMBARK trial have shown that treatment with enzalutamide maintains patients' quality of life. A presentation at the 2024 ASCO Annual Meeting demonstrated that suspending enzalutamide treatment in patients with good PSA response did not negatively impact quality of life measures, offering potential for intermittent therapy approaches.

What's Next?

Researchers suggest future studies should explore:

  • True intermittent therapy approaches with enzalutamide
  • The impact of next-generation imaging technologies on treatment decisions
  • Benefits for patient populations underrepresented in current studies

For patients with biochemical recurrence after primary treatment for prostate cancer, these findings provide additional evidence to guide treatment decisions, particularly for those meeting high-risk criteria.

References

  1. De Giorgi U, Freedland SJ, Rannikko A, et al. Enzalutamide in patients with high-risk biochemically recurrent prostate cancer according to the European Association of Urology definition: a post hoc analysis of EMBARK. Prostate Cancer and Prostatic Diseases. 2025. https://doi.org/10.1038/s41391-025-00959-8
  2. Freedland SJ, de Almeida Luz M, De Giorgi U, et al. Improved outcomes with enzalutamide in biochemically recurrent prostate cancer. N Engl J Med. 2023;389(16):1453-1465. https://www.nejm.org/doi/full/10.1056/NEJMoa2303974
  3. Freedland SJ, Gleave M, De Giorgi U, et al. Enzalutamide and quality of life in biochemically recurrent prostate cancer. NEJM Evid. 2023;2(12)
    . https://pubmed.ncbi.nlm.nih.gov/38320501/
  4. "Xtandi Approved for High-Risk Prostate Cancer." National Cancer Institute, 2024. https://www.cancer.gov/news-events/cancer-currents-blog/2024/fda-xtandi-prostate-cancer-psa-recurrence
  5. "Enzalutamide Suspension in nmHSPC Does Not Affect QOL in EMBARK Trial." Targeted Oncology, June 2, 2024. https://www.targetedonc.com/view/enzalutamide-suspension-in-nmhspc-does-not-affect-qol-in-embark-trial
Enzalutamide in patients with high-risk biochemically recurrent prostate cancer according to the European Association of Urology definition: a post hoc analysis of EMBARK | Prostate Cancer and Prostatic Diseases

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