Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer
Status:
Completed
Trial end date:
2004-10-01
Target enrollment:
Participant gender:
Summary
Objective was to evaluate the efficacy and safety of the histrelin acetate subdermal implant
(originally versus Lupron Depot-3 Month) in male patients with advanced prostate cancer
during 52 weeks of treatment with the implant. After consultation w/ FDA, design was modified
to eliminate the Lupron arm and continued the study as an open-label non-randomized study.
Primary endpoint was testosterone suppression, as assessed by the percent of patients whose
testosterone indicated chemical castration levels (<=50 ng/dL) through 52 weeks of treatment
with an implant.