Efficacy and safety of leuprolide acetate 6-month depot for suppression of testosterone in patients with prostate cancer.

ABSTRACT:

Background

This open-label study evaluated the efficacy and safety of a new leuprolide acetate 45 mg 6-month depot formulation in 151 men with prostate cancer who received 2 intramuscular injections administered 24 weeks apart.

Methods

The primary efficacy measurement was the proportion of patients achieving suppression of serum testosterone to ≤ 50 ng dl(-1) from week 4 through week 48. Adverse events (AEs) and hormonal and safety laboratory values were monitored.

Results

The primary efficacy end point was achieved in 93.4% of subjects (95% confidence interval (89.2%, 97.6%)). There were nine escapes from testosterone suppression during the study, none of which were accompanied by a rise in PSA. By week 4, mean testosterone concentration was suppressed below castrate

SUBMITTER: Spitz A 

PROVIDER: S-EPMC3278745 | biostudies-literature | 2012 Mar

REPOSITORIES: biostudies-literature