Table 2.
Reasons for Discontinuation
| Reason | Control | Low-dose | High-dose | Total |
|---|---|---|---|---|
| Disease progression | 3 | 7 | 5 | 15 |
| Withdrew consent | 3 | 5 | 4 | 12 |
| Toxicity | 0 | 0 | 1 | 1 |
| Comorbidities | 2 | 2 | 2 | 6 |
| Othera | 3 | 7 | 5 | 15 |
All reasons given for stopping treatment prior to 12 cycles.
Other reasons: rising PSA not meeting protocol defined progression (Control:2, Low:5, High:2), 4 disenrolled before treatment (Control:1, Low:1, High:2), patient stopped taking study drug (High:1), patient transferred to another facility (Low:1)