Methods |
Multicenter
Randomization: Not specified
Double‐blinded: NA
Withdrawals documented: partial
Intention‐to‐treat analysis (ITT): modified |
Participants |
Geographic setting: Germany
Number enrolled: 99
Number randomized, control: 45
Number analyzed, control: 45
Number randomized, treatment: 54
Number analyzed, treatment: 54
Median/mean age control group: No details
Median/mean age treatment group: No details |
Interventions |
Control: bilateral orchiectomy or goserelin 3.6 mg sc
Treatment: bilateral orchiectomy or goserelin 3.6 mg sc plus flutamide 750 mg
Median time to follow‐up: NA
Lost to follow‐up: Control 5; Treatment 5
# not completed: Control 5; Treatment 5 |
Outcomes |
Overall survival
Cancer‐specific survival
Progression‐related outcomes
Time to treatment failure
Adverse events |
Notes |
Percentage M1 disease, control: NS
Percentage M1 disease, treatment: NS
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 |