| Methods |
Randomization: Central dynamic centralization
Double‐blinded: yes
Withdrawals documented: partial
Intention‐to‐treat analysis (ITT): modified |
| Participants |
Geographic setting: US
Number enrolled: 617
Number randomized, control: 300
Number analyzed, control: 300
Number randomized, treatment: 303
Number analyzed, treatment: 303
Median/mean age control group: 67
Median/mean age treatment group: 67 |
| Interventions |
Control: leuprolide 1 mg sc q.d. plus placebo
Treatment: leuprolide 1 mg sc q.d. 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: 100%
Percentage M1 disease, treatment: 100%
Percentage poorly differentiated tumor, control: NA
Percentage poorly differentiated tumor, treatment: NA |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
