Table 4. Response after two cycles .
| n=15 | Objective response | Patient reported outcomes | ||||
|---|---|---|---|---|---|---|
| RECIST* | PSA | Pain | QoL | |||
| After one cycle | ||||||
| CR | - | 0 | 1 (7%) | - | ||
| PR | - | 7 (47%)** | 6 (40%) | - | ||
| SD | - | 5 (33%) | 2 (13%) | - | ||
| PD | - | 3 (20%) | 1 (7%) | - | ||
| After two cycles | ||||||
| CR | 0 | 0 | 3 (20%) | 0 | ||
| PR | 4 (27%) | 7 (47%)** | 4 (27%) | 3 (20%) | ||
| SD | 6 (40%) | 5 (33%) | 0 | 11 (73%) | ||
| PD | 5 (33%) | 3 (20%) | 3 (20%) | 1 (7%) | ||
*
primary outcome,
**
≥30% decline in PSA; Abbreviations: RECIST, Response Evaluation Criteria in Solid Tumors; PSA, Prostate-Specific Antigen; QoL, quality of life; SD, stable disease; PR, partial response; PD, progressive disease; CR, complete response.