| Methods |
Multicenter
Randomization: central randomization by telephone contact
Double‐blinded: no
Withdrawals documented: yes
Intention‐to‐treat analysis (ITT): modified |
| Participants |
Geographic setting: Italy
Number enrolled: 373
Number randomized, control: 186
Number analyzed, control: 186
Number randomized, treatment: 187
Number analyzed, treatment: 187
Median/mean age control group: 74
Median/mean age treatment group: 73 |
| Interventions |
Control: goserelin 3.6 mg sc
Treatment: goserelin 3.6 mg sc plus flutamide 750 mg
Median time to follow‐up: 24 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: 68%
Percentage M1 disease, treatment: 62%
Percentage poorly differentiated tumor, control: 30%
Percentage poorly differentiated tumor, treatment: 25% |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
