| Methods |
Multicenter
Randomization: Not specified
Double‐blinded: no
Withdrawals documented: partial
Intention‐to‐treat analysis (ITT): modified |
| Participants |
Geographic setting: Europe
Number enrolled: 589
Number randomized, control: 284
Number analyzed, control: 284
Number randomized, treatment: 287
Number analyzed, treatment: 287
Median/mean age control group: 73
Median/mean age treatment group: 72 |
| Interventions |
Control: goserelin 3.6 mg sc
Treatment: goserelin 3.6 mg sc plus flutamide 750 mg
Median time to follow‐up: 56.2 months
Lost to follow‐up: NA |
| Outcomes |
Overall survival
Cancer‐specific survival
Progression‐related outcomes
Time to treatment failure
Adverse events |
| Notes |
Percentage M1 disease, control: 58%
Percentage M1 disease, treatment: 56%
Percentage poorly differentiated tumor, control: 16%
Percentage poorly differentiated tumor, treatment: 12% |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
