| Methods |
Multicenter
Randomization: Balanced by treating institution
Double‐blinded: yes
Withdrawals documented: partial
Intention‐to‐treat analysis (ITT): none |
| Participants |
Geographic setting: France
Number enrolled: 151
Number randomized, control: 60
Number analyzed, control: 53
Number randomized, treatment: 65
Number analyzed, treatment: 45
Median/mean age control group: 72
Median/mean age treatment group: 72 |
| Interventions |
Control: bilateral orchiectomy plus placebo
Treatment: bilateral orchiectomy plus nilutamide 300 mg
Median time to follow‐up: 23.4 months
Lost to follow‐up: NA
# not completed: Control 4; Treatment 8 |
| Outcomes |
Overall survival
Cancer‐specific survival
Progression‐related outcomes
Time to treatment failure
Adverse events |
| Notes |
Percentage M1 disease, control: 100%
Percentage M1 disease, treatment: 97%
Percentage poorly differentiated tumor, control: 34%
Percentage poorly differentiated tumor, treatment: 53% |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
