PREVAIL

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Beer TM, et al. "Enzalutamide in metastatic prostate cancer before chemotherapy". The New England Journal of Medicine. 2014. 2014-06-01:1-10.
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Clinical Question

Bottom Line

Major Points

Guidelines

Design

  • N=1,717
    • Enalutamide (n=872)
    • Placebo (n=845)
  • Setting:
  • Enrollment:
  • Mean follow-up:
  • Analysis:
  • Primary outcomes:
    • Radiographic PFS
    • Overall survival

Population

Inclusion Criteria

Exclusion Criteria

Baseline Characteristics

From the enzalutamide group.

  • Demographics: Age 72 years (<65 years 21%, 65-74 years 43%, ≥75-84 years 31%, ≥85 years 5%)
    • American Indian or Alaska Native: 0.1%
    • Asian: 10%
    • Black or African American: 2%
    • Native Hawaiian or Pacific Islander: 0.1%
    • White: 77%
    • Other: 11%
    • Ethnicity: Not Hispanic or Latino 90%, Hispanic or Latino 2%, unknown 8%
  • Baseline health data: Weight 83 kG, BMI 27 kg/m2, Hgb 13 g/dL, alk phos 94 units/L, LDH 185 units/L, albumin 3.8 g/dL, PSA 54 ug/L, creatinine 85.0 umol/L
  • ECOG status:
    • 0: 67%
    • 1: 33%
    • ≥2: 0
  • Baseline BPI-SPF question 3 pain score
    • 0-1: 66%
    • 2-3: 32%
    • >3: 2%
  • Disease-specific:
    • Time from diagnosis or first treatment to randomization: 63 months
    • Type of disease progression at study entry:
      • PSA: 43%
      • Radiographic + PSA progression: 40%
      • Radiographic - PSA progression: 14%
      • No disease progression per protocol: 3%
    • Disease localization:

Interventions

Outcomes

Presented as enzalutamide vs. placebo.

Primary Outcomes

Radiographic PFS
65% vs. 14% (HR 0.19; 95% CI 0.15-0.23; P<0.001)
Overall survival
28% vs. 35% (HR 0.71; 95% CI 0.60-0.84; P<0.001)

Secondary Outcomes

Time until initiation of cytotoxic chemotherapy
28.0 vs. 10.8 months (HR 0.35; 95% CI 0.30-0.40; P<0.001)
Time until first skeletal event
31.1 vs. 31.3 months (HR 0.63; 95% CI 0.54-0.72; P<0.001)
Best overall soft-tissue response
Time until PSA progression
Decline in PSA level ≥ 50% from baseline

Additional Analyses

Prespecified exploratory outcomes

Subgroup Analysis

Adverse Events

 % vs. % (## HR; 95% CI ##-##; P=##; NNH=##)

Criticisms

Funding

Further Reading