Study of Histrelin Subdermal Implant in Patients With Prostate Cancer
Completed
Endo Pharmaceuticals
Phase 3
2000-05-01
This trial was an open-label, multi-national, randomized, parallel treatment, active-control
multicenter study in adult males with documented metastatic prostate cancer disease who were
judged to be candidates for hormone therapy.
Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer
Completed
Endo Pharmaceuticals
Phase 3
2000-04-01
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.
Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer
Unknown status
University of Colorado, Denver
Phase 2
2015-11-11
This randomized phase II trial compares enzalutamide with standard androgen deprivation
therapy in reducing incidence of metabolic syndrome in patients with prostate cancer that has
spread to other places in the body. Metabolic syndrome is defined as changes in cholesterol,
blood pressure, circulating sugar levels, and body weight. Previous studies have shown that
patients with prostate cancer, who have been treated with standard medical therapy that
lowers testosterone levels, have an increased risk of these changes. Hormone therapy using
enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells
instead of lowering testosterone levels. It is not yet known whether prostate cancer patients
who receive enzalutamide will have reduced incidence of metabolic syndrome than patients who
receive standard androgen deprivation therapy.
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