PREVAIL (Prostate Cancer)

Incomplete

Beer TM, et al. "Enzalutamide in metastatic prostate cancer before chemotherapy". The New England Journal of Medicine. 2014. 2014-06-01:1-10.
PubMed • Full text • PDF

Design

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

Population

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:

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

Adverse Events

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