Table 1. Patient clinical and characteristics.
Characteristics | Number of subjects | Median progression-free survival (month) | P value |
---|---|---|---|
Age at ketoconazole therapy, median 71 years (range 50–83 years) | 0.213 | ||
<71 years | 79 | 3.0 | |
≥71 years | 84 | 2.6 | |
Clinical T stage | 0.239 | ||
T2 | 66 | 3.0 | |
T3–4 | 33 | 2.8 | |
Unknown | 64 | 2.0 | |
Metastasis site | 0.778 | ||
Lymph nodes only | 10 | 3.0 | |
Bone only | 132 | 2.7 | |
Lymph nodes and bone | 16 | 2.6 | |
Internal organ | 5 | 2.8 | |
Biopsy Gleason score | 0.041 | ||
4–6 | 72 | 3.1 | |
7 | 70 | 1.9 | |
8–10 | 21 | 3.0 | |
Nadir PSA | <0.001 | ||
<0.2 ng ml−1 | 70 | 3.5 | |
≥0.2 ng ml−1 | 93 | 1.4 | |
PSADT | 0.025 | ||
<2.0 months | 62 | 1.9 | |
≥2.0 months | 101 | 3.0 | |
Baseline PSA | 0.615 | ||
<20 ng ml−1 | 76 | 2.8 | |
≥20 ng ml−1 | 87 | 2.6 | |
Baseline testosterone | <0.001 | ||
<0.1 ng ml−1 | 76 | 1.6 | |
≥0.1 ng ml−1 | 87 | 3.1 | |
Baseline haemoglobin | 0.004 | ||
Normal (≥120 g l−1) | 93 | 2.8 | |
Less than normal | 70 | 1.9 | |
Baseline alkaline phosphatase | 0.004 | ||
Normal (≤130 IU l−1) | 66 | 3.0 | |
Greater than normal | 97 | 1.9 | |
Docetaxel chemotherapy | 0.517 | ||
Yes | 11 | 2.0 | |
No | 152 | 2.6 |
Abbreviations: PSA, prostate-specific antigen; PSADT, PSA doubling time.
The cutoffs for the nadir PSA and PSADT were based on the literature; the cutoffs for the baseline PSA and testosterone were based on the Youden index; the cutoffs for the baseline haemoglobin and alkaline phosphatase were the limiting value of the normal level.
The P value was calculated by the univariate Cox regression analysis.