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Título

HIGH-RISK BIOCHEMICALLY RECURRENT PROSTATE CANCER IN A BRAZILIAN POPULATION: A SUB-ANALYSIS OF THE EMBARK STUDY

Resumo

Introduction: Biochemical recurrence (BCR), which is characterized by increasing levels of
prostate-specific antigen (PSA), following definitive treatment for localized or locally advanced
prostate cancers occurs in ∼20-50% of patients in 10 years. Patients with high-risk BCR have an
increased risk of mortality and improved therapies are an unmet need. EMBARK, a phase 3
randomized study of enzalutamide or placebo plus leuprolide acetate and enzalutamide
monotherapy in high-risk biochemically recurrent prostate cancer has been recently published
and enrolled patients from 17 countries, including Brazil.
Objective: To describe baseline characteristics of the Brazilian population enrolled in the
EMBARK study.
Methods: EMBARK is a randomized, phase 3 study of patients with BCR considered high-risk:
PSA doubling time (PSADT) ≤9 months and PSA ≥2 ng/mL above nadir post-radiotherapy (RT) or
≥1 ng/mL after radical prostatectomy (RP) ± postoperative RT. This is a descriptive post-hoc
analysis of baseline characteristics of the Brazilian population enrolled in the EMBARK study.
Results: A total of 59 Brazilian patients were enrolled in the study. Patients’ characteristics can
be found in Table 1. The median PSADT was 5.1 months. Regarding definitive treatment, 44.1%
of patients received primary radiotherapy (RT) and 55.9% underwent radical prostatectomy,
either alone (15.2%) or followed by salvage RT (40.7%).
Conclusion: Most Brazilian patients enrolled in the EMBARK trial had a short PSADT (≤ 6 mo). RP
was the main primary treatment and most of those patients underwent salvage RT.
Study funded by Astellas Pharma.