| Methods |
Randomization: Not specified
Double‐blinded: No
Withdrawals documented: partial
Intention‐to‐treat analysis (ITT): none |
| Participants |
Geographic setting: Italy
Number enrolled: 150
Number randomized, control: 76
Number analyzed, control: 62
Number randomized, treatment: 74
Number analyzed, treatment: 63
Median/mean age control group: 72
Median/mean age treatment group: 69 |
| Interventions |
Control: leuprolide IM (no dose given) x 28d; cyproterone 150 mg given for 3 weeks.
Treatment: leuprolide IM (no dose given) plus flutamide 750 mg Median time to follow‐up: 30 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: 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) |
Unclear risk |
D ‐ Not used |
