Table 1.

Patient characteristics divided by prior chemotherapy treatment

Chemotherapy naiveDocetaxel treated
Total no. patients5435
    Bone metastasis41 (75%)33 (94%)
    Soft tissue metastasis31 (57%)21 (60%)
    No radiologically detectable metastases4 (7%)0
    Median pretreatment PSA (ng/mL)88 (range, 8.8–964)501 (range, 26.4–10,325)
    CTC of ≥4 at any time point on study22 (40%)29 (82%)
FISH results on CTC2029
    ERG rearranged8 (40%)15 (51%)
        Class Edel5 (62%)10 (66%)
        Class Esplit3 (38%)5 (34%)
    PTEN loss6 (30%)7 (24%)
        Homozygous45
        Heterozygous22
    AR copy number gain
        4/5 copies of AR (maximum)2 of 11 (18%)8 of 22 (36%)
        >5 copies of AR (maximum)7 of 11 (63%)8 of 22 (36%)
  • NOTE: ERG and PTEN CTC gene status was available for 49 of 51 patients (96%) with four or more CTCs at any time point on study. AR copy number was evaluated in 33 of 51 patients (64%) with four or more CTCs at any time point on study (maximum copy number observed is reported).