| Methods |
Multicenter
Randomization: Stratified by participating center, local block randomization
Double‐blinded: no
Withdrawals documented: partial
Intention‐to‐treat analysis (ITT): yes |
| Participants |
Geographic setting: Denmark
Number enrolled: 264
Number randomized, control: 133
Number analyzed,control: 133
Number randomized, treatment: 129
Number analyzed, treatment: 129
Median/mean age control group: 72
Median/mean age treatment group: 72 |
| Interventions |
Control: total or subcapsular bilateral orchiectomy
Treatment: goserelin 3.6 mg sc plus flutamide 750 mg
Median time to follow‐up: 57 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:89%
Percentage M1 disease, treatment: 93%
Percentage poorly differentiated tumor, control: 63%
Percentage poorly differentiated tumor, treatment: 50% |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
