Methods |
Multicenter
Randomization: No details
Double‐blinded: yes
Withdrawals documented: no
Intention‐to‐treat analysis (ITT): none |
Participants |
Geographic setting: Switzerland
Number enrolled: 51
Number randomized, control: 25
Number analyzed, control: 20
Number randomized, treatment: 26
Number analyzed, treatment: 19
Median/mean age control group: 74
Median/mean age treatment group: 74 |
Interventions |
Control: bilateral orchiectomy plus placebo
Treatment: bilateral orchiectomy plus nilutamide 300 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: 96%
Percentage M1 disease, treatment: 92%
Percentage poorly differentiated tumor, control: NS
Percentage poorly differentiated tumor, treatment: NS |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |