Efficacy and safety of leuprolide acetate 6-month depot for suppression of testosterone in patients with prostate cancer
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 patient...
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Published in | Prostate cancer and prostatic diseases Vol. 15; no. 1; pp. 93 - 99 |
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Main Authors | , , , , , |
Format | Journal Article |
Language | English |
Published |
London
Nature Publishing Group UK
01.03.2012
Nature Publishing Group |
Subjects | |
Online Access | Get full text |
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Summary: | 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 levels to 15.9 ng dl
−1
; suppression was maintained for the entire 24-week duration of each depot injection. No mean increase in testosterone was observed after the second injection. Mean PSA levels were maintained below 3 ng ml
−1
from week 14 through the 48-week treatment period. The most frequent AE was flushing (58.3%). Injection site reactions were reported in 24.5% of patients.
Conclusions:
Leuprolide acetate 45 mg 6-month depot demonstrated rapid and sustained testosterone suppression through 12 months and was well tolerated. This 6-month leuprolide acetate depot will decrease the number of annual injections in the treatment of prostate cancer. |
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Bibliography: | Died October 31, 2010. |
ISSN: | 1365-7852 1476-5608 |
DOI: | 10.1038/pcan.2011.50 |