Table 1.

Demographics and Disease Characteristics of Enrolled Patients (n = 60)

Patient Demographics and Clinical Characteristics	No.	%
Age, years
Median	66
Range	44-79
Race
White	49	82
African American	9	15
Hispanic	2	3
Gleason score at diagnosis
Median	8
Range	5-10
≥ 8	39	65
≤ 7	20	33
Unclassified	1	2
Prior treatment
Prostatectomy	56	93
Radiotherapy	6	10
Neoadjuvant/adjuvant therapy	6	10
Secondary hormonal therapy	57	95
On-study PSA, ng/mL
Median	99
Range	0.9-4,399.0*
Prestudy PSA doubling time, months
Median	1.6
Range	0.3-18.2
Metastases
Bone only	23	38
Soft tissue only	6	10
Bone and soft tissue	31	52
Visceral involvement	8	13
Patients with measurable disease according to RECIST	33	55
Hemoglobin, g/dL
Median	12.7
Range	8.3-14.3
Lactate dehydrogenase, U/L
Median	191
Range	112-1,280
Alkaline phosphatase, U/L
Median	107
Range	45-720
ECOG performance status
0	8	13
1	48	80
2	4	7
Pain at baseline	29	48
Predicted survival, months†
Median	14
Range	< 6-27

Abbreviations: PSA, prostate-specific antigen; RECIST, Response Evaluation Criteria in Solid Tumors; ECOG, Eastern Cooperative Oncology Group.

^*One patient had no detectable PSA activity.

^†Based on the Halabi survival nomogram.²⁴