Patients were eligible to participate in the study
if they had histologically or cytologically confirmed
prostate cancer that had previously been
treated with docetaxel, disease progression according
to the criteria of the Prostate Cancer
Working Group21,22 (for trial entry, patients were
considered to have disease progression if they
had two consecutive increases in the PSA concentration
over a reference value) or radiographic evidence
of disease progression in soft tissue or bone
with or without disease progression on the basis
of the PSA value, and ongoing androgen deprivation,
with a serum testosterone level of 50 ng per
deciliter or less (≤2.0 nmol per liter).