Table 1.

Baseline clinical characteristics

Patient characteristics
Number of patients treated60
Median age (years)67 years (45–87)
Prior local therapy (surgery or radiation)37 (61%)
 Gleason grade8
 66 (13%)
 715 (33%)
 8–1026 (59%)
Median PSA (ng/mL)1.07 (0.01–514.2)
 Sites of metastases
 Bone47 (78%)
 Lymph node45 (75%)
 Lung22 (37%)
 Liver36 (60%)
 Any visceral41 (68%)
Elevated LDH29/57 (51%)
Median number of prior systemic therapies for CRPC3
 Platinum35 (58%)
 Enzalutamide or abiraterone24 (40%)
 Docetaxel19 (32%)
 Cabazitaxel6 (10%)
 Radium-2231 (2%)
Histologic diagnosis of NEPC by local review (inclusion criteria 1)45 (75%)
 Prostate adenocarcinoma plus ≥50% IHC staining for neuroendocrine markers (inclusion criteria 2)11 (18%)
Development of liver metastases in the absence of PSA progression (inclusion criteria 3)15 (25%)
 Serum chromogranin >5× ULN and/or NSE>2× ULN (inclusion criteria 4)18 (30%)
Median time from prostate cancer diagnosis to dose (months)44.23 (3.9–1,313)
  • NOTE: A total of 75 patients were screened and 60 patients were treated.