| Methods |
Multicenter
Randomization: Not specified
Double‐blinded: yes
Withdrawals documented: no
Intention‐to‐treat analysis (ITT): yes |
| Participants |
Geographic setting: France
Number enrolled: 245
Number randomized, control: 125
Number analyzed, control: 125
Number randomized, treatment: 120
Number analyzed, treatment: 120
Median/mean age control group: 74
Median/mean age treatment group: 74 |
| Interventions |
Control: goserelin 3.6 mg sc
Treatment: goserelin 3.6 mg sc plus flutamide 750 mg
Median time to follow‐up: NA
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: 84%
Percentage M1 disease, treatment: 81%
Percentage poorly differentiated tumor, control: 39%
Percentage poorly differentiated tumor, treatment: 40% |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
